- Asthma and Weight Gain
- Asthma Medication Side Effects
- Tips for Avoiding Weight Gain
- Asthma and Weight Gain: Prevention Starts Early
- Breath of Fresh Air: Feature Articles
- Chapter 44: What are the side effects of the inhaled steroids if used for many years?
- Breo Ellipta
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
- Breo Ellipta Side Effects
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Breo Ellipta (fluticasone / vilanterol)
- Breo Ellipta Facts
- FDA Approval
- Uniqueness of Product
- Breo Dosage and Administration
- Side Effects Possible with Breo
- Warnings and Precautions
- Breo Ellipta Black Box Warning
- Finding Help for a Breo Lawsuit Near Me
Asthma and Weight Gain
Most people know about the usual weight-gain suspects — eating too much unhealthy food or spending too much time on the couch, for instance. But for people with asthma, there’s an additional factor — their medication. Weight gain can be an unfortunate side effect of oral steroids, taken in pill or inhaler form to treat asthma.
There is a proven link between weight gain and oral steroids, says Christine Gerbstadt, MD, RD, registered dietitian and spokesperson for the American Dietetic Association. The reason? “Steroids simply increase your appetite,” says Dr. Gerbstadt, adding that steroids raise blood glucose levels and cause other metabolic changes that not only put the patient at risk of gaining weight, but perhaps even developing diabetes.
Asthma Medication Side Effects
Weight gain is a less common medication side effect when steroids are taken through asthma inhalers as opposed to oral medications because the doses administered through asthma inhalers are far lower and go straight to the lungs, explains Gerbstadt.
In contrast, other asthma medications such as beta-agonist bronchodilators, which relieve the symptoms of asthma by relaxing the muscle of the bronchial tubes, are not associated with weight gain, but they have their own medication side effects. “Beta-agonists can cause jitteriness, dilate pupils, and increase heart rate,” says Gerbstadt.
There is also an unhealthy cycle connected to asthma and weight. People with asthma may be reluctant to exercise for fear of triggering their asthma symptoms. Lack of exercise can contribute to weight gain. And being overweight can, in turn, make exercise more difficult because excess weight can compress your lungs and make breathing during exercise more difficult. Weight loss, therefore, can help improve your asthma and help improve your workouts.
Tips for Avoiding Weight Gain
To prevent weight gain, people with asthma should first and foremost eat less, says Gerbstadt. Cutting back is important, she says, but understands that it’s easier said than done. “Most people are not used to going hungry.”
Try these other ideas for preventing weight gain when you have asthma:
- Eat lots of veggies. Crunchy, water-filled vegetables such as celery or carrots are an excellent choice.
- Include whole grains in your diet. “People worry about carbs, but if all you ate were brown rice and whole grain bread, you could eat a lot without worry about weight gain,” says Gerbstadt.
- Find good flavorings. If you need to use dips or other flavorings to jazz up veggies, try salsa or low-fat marinara sauce. Other good options include hummus and yogurt.
- Drink plenty of water. “A lot of people mistake thirst for hunger,” says Gerbstadt. “Drink room temperature water, which is more filling than ice water.” Other good options for hydration are herbal or green tea or warm broth, which can help make you feel full, says Gerbstadt.
- Cut down on fat. Air-popped popcorn or baked potatoes with yogurt instead of chips are great snack choices, says Gerbstadt. Use herbs and spices to flavor food instead of cream or butter.
- Relearn portion sizes. Find out what foods and in what amounts you should be eating and stick to those recommendations.
- Don’t forget to move. “Walk. Do jumping jacks when you’re watching TV and commercials are on — it all adds up,” says Gerbstadt.
Asthma and Weight Gain: Prevention Starts Early
Gerbstadt’s advice is followed within her own family — her son, now 6 years old, has childhood asthma. “His asthma started off when he had a cold, and then would go away,” Gerbstadt explains. To better manage his asthma, he eats a healthy diet, a habit that was fostered at a young age. “He likes to eat grilled fish with veggies,” says Gerbstadt.
The youngster follows a three-pronged approach to staying healthy with asthma — he participates in sports, follows a nutritious diet, and manages his asthma, and weight gain has not been an issue for him, she says.
No matter what your age, choosing foods wisely and getting regular exercise are important lifestyle habits for preventing weight gain and living well with asthma.
Women with asthma are more likely to gain weight from inhaled corticosteroids (ICSs) than men, according to a recent study published by the International Scholarly Research Network Pulmonology.
The study included 180 patients between 18 and 75 years with physician-diagnosed asthma in Montreal, Canada. Researchers interviewed participants on their overall medical history, asthma history, height, and weight. Participants then completed the same interview after 1 year. Researchers used statistical analysis to test the relationship between ICS dosage and sex and its effect on weight. Age, smoking status, and duration of asthma were taken into consideration while compiling results.
Results showed that women taking higher dosages of ICSs gained more weight over 1 year, with an average gain of 2.1 lb. Men, however, lost weight with higher doses of ICSs, with an average loss of 2.9 lb.
The findings suggest an association between asthma and weight gain in women. “Further research is needed to clarify the extent to which this relationship is influenced by sex hormones, dietary and exercise behaviours, and medication adherence, in order to further elucidate possible mechanisms,” the researchers noted.
Use with caution in
- Active or inactive tuberculosis infection affecting the lungs.
- Herpes simplex virus infection of the eye.
- Untreated viral, bacterial or fungal infection affecting the rest of the body.
Not to be used in
- Children under 12 years of age.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. The manufacturer states that it is not recommended for use in pregnancy unless considered essential by your doctor. However, it is important that asthma is well controlled in pregnant women. Wherever possible, asthma medications should be taken by inhaler, as this minimises the amount of medicine that enters the bloodstream and crosses the placenta. It is important to get medical advice from your doctor on how to control your asthma during pregnancy, but in general, inhaled medicines can be taken as normal during pregnancy.
- In general, the amount of corticosteroid that passes into the breast milk after using an inhaler is negligable and probably too small to be harmful to the baby. However, it is not known if mometasone passes into breast milk and you should seek medical advice from your doctor before breastfeeding while using this medicine.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Common (affect between 1 in 10 and 1 in 100 people)
- Yeast infection of the mouth and throat (oral thrush – see warning above).
- Hoarse voice.
- Inflammation of the throat (pharyngitis).
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Dry mouth and throat.
- Weight gain.
- Awareness of your heartbeat (palpitations).
- Unexpected narrowing of the airways (paradoxical bronchospasm – see warning section above).
- Allergic reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), itchy blistering rash or anaphylactic shock.
- Systemic effects (eg, Cushing’s syndrome, adrenal suppression, slowed growth in children and adolescents, decreased bone mineral density, cataract and glaucoma) may occur after high doses for prolonged periods – see warning above.
The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
Tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
The following medicines may increase the amount of mometasone that is found in the bloodstream after inhaling the medicine:
- protease inhibitors for HIV infection, such as nelfinavir or ritonavir.
Mometasone may be less effective at preventing asthma attacks for three to four days after taking the medicine mifepristone (used for termination of pregnancy or inducing labour if the baby has died in the womb).
Other medicines containing the same active ingredient
There are currently no other asthma medicines containing mometasone furoate available in the UK.
Other medicines that contain mometasone include Nasonex nasal spray (for hayfever), Elocon cream and ointment (for eczema) and Elocon scalp lotion (for dermatitis or psoriasis affecting the scalp).
Last updated 27.03.2013
So the debate goes on. You’ve noticed bruising on your legs that don’t go away, and you’ve gained weight since you started using it. Yet they say it can’t be the new medicine. So the question is: Does Advair Cause Weight Gain?
Here’s my take on this very common concern in a recent post at MyAsthmaCentral.com
Does Advair Cause Weight Gain?
Weight gain while using Advair is something that has been discussed a lot in asthma communities, as you can see here and here and here and here and here and here. Yet there has been very little documented evidence as to whether it is true or not.
I was recently asked, “Does Advair cause weight gain?” My answer here was a swift, “Studies have shown that if you rinse your mouth out really well after using your Advair inhaler systemic side effects are very rare.”
Yet considering the broad discussions on this topic, I’m now wondering if my answer was, perhaps, not quite complete. Is it possible that Advair does cause weight gain, even with a good mouth rinse?
The answer: it’s possible.
Asthma.emedtv.com notes that while weight gain was not listed among the side effects of Advair during initial testing; many asthmatics on Advair have noted weight gain.
In fact, more recently, weight gain has been added as a possible side effect as you can see for yourself in section 6.3 of this Advair insert.
Although it’s mentioned under the following note: “Because (this side effect is) reported voluntarily from a population of unknown size, estimates of frequency cannot be made.”
So it’s obvious there have been more than a few with the complaint of weight gain while using Advair. At least enough to make weight gain worth noting under possible side effects.
Systemic corticosteroids, the kind given by IV or by mouth, can cause systemic side effects, including weight gain. When I’m on them — and thankfully I haven’t needed them in over 10 years — I get an insatiable appetite (yep, I’d eat my fries and then finish yours too). Weight gain was inevitable.
Yet, despite old fears, studies have shown inhaled corticosteroids, including Advair, are safe, and side effects rare, so long as you rinse your mouth out. And this is still true for the most part, and for most patients.
I know I have seen some websites note that the higher dose (500/50) of Advair has been linked to increased side effects, as compared with the lower doses (100/50 and 250/50).
So, this makes me wonder if I might have been correct, and perhaps all those folks complaining of Advair weight gain were either on the higher dose, or not rinsing their mouths out properly.
Still, for some reason that doesn’t seem plausible.
Another consideration that might cause weight gain for some who take Advair, and this is listed as a possible side effect, is possible fluid retention — which may lead to weight gain.
Of course fluid retention is also a complication of illnesses such as heart and kidney failure, so if you have this then you ought to be calling your doctor to rule out other illnesses.
Only after other causes (including lack of activity) are ruled out can we start thinking that weight gain might be caused by a medicine such as Advair.
My coworker attended a class to prepare her for becoming an asthma educator a few years ago, and she learned studies showed being on a small amount of corticosteroid all the time (such as is provided by the daily use of Advair), is much safer than short bursts of corticosteroids.
So again, one must weigh the advantages of taking any medicine with the disadvantages. In the case of Advair, and for most patients, the benefits far outweigh the disadvantages.
As far as my experience with weight gain and Advair, in the past (back in 2002) when I did the Body For Life diet I lost up to 40 pounds in one 12 week period. Yet recently (after gaining my weight back because I’m normal) I only lost 20 pounds in 20 weeks. Now this could be age catching up to me, or the fact I didn’t stick to the diet as well as I did in the past.
Yet — and this idea crossed my mind — it could be that I am now on Advair.
One of the advantages of Advair is you only have to take it twice a day, which I usually do just prior to brushing my teeth in the morning and at night.
In this way I don’t miss doses like I used to. These results not only in better asthma control, but it also might increase my risk for side effects.
So, when I lost weight in 2002 I was not on Advair, I was using a Flovent inhaler and I often missed doses. Likewise, I did not use a spacer back then (a goofus perhaps?), which may have reduced the amount of corticosteroid in my system even further.
In essence, Advair improved my compliance and my technique, which results in better medicine distribution to my lungs. Could this possibly have also resulted in more side effects — like weight gain?
Of course I am only speculating. Yet I know I’m not alone in thinking this way, as you can see by the discussions linked to above.
Some of us, however, may simply be trying to blame Advair for weight gain, when we should be blaming ourselves. A good diet and exercise can help one maintain a good weight. I’m not blaming the Advair, I’m just curious.
Still it would be neat to see further studies in this area.
That said I would never quit taking Advair. Never in my life had I had better asthma control than since I started this great medicine.
While side effects vary from person to person, and despite the warnings, they are still rare and minimal when they do occur. I highly recommend you discuss with your doctor trying Advair if other medicines don’t give you the results you yearn for.
So what do you think? What is your experience with Advair and weight gain? Are there studies I’m not aware of? Discuss..
Breath of Fresh Air: Feature Articles
Chapter 44: What are the side effects of the inhaled steroids if used for many years?
When steroid tablets are taken for many months or years, harmful side effects are likely and almost inevitable. The list of possible effects is long; it includes mood changes, forgetfulness, hair loss, easy bruising, a tendency toward high blood pressure and diabetes, thinning of the bones (osteoporosis), suppression of the adrenal glands, muscle weakness, weight gain, cataracts, and glaucoma. After being swallowed, these tablets are absorbed from the stomach into the bloodstream and taken not only to the bronchial tubes (to treat asthma) but also to every other part of the body. Their effects are widespread.
On the other hand, only miniscule amounts of steroid medication enter the bloodstream after inhaling it. The reasons for this difference include the following. First, steroids used for inhalational treatment of asthma are designed not cross well from the surface of the bronchial tubes into the bloodstream. Somewhat like applying a steroid cream to the skin, they are poorly absorbed from the surface into the blood. Second, only very small amounts of steroid medication are delivered from the inhalers with each dose or “puff.” Less medicine is needed when it can be directly applied to the affected area. We measure the amounts of steroids inhaled in micrograms, which are units one thousand times smaller than the milligrams by which we measure prednisone or Medrol® tablets.
When breathed in, some steroid medicine remains in the mouth and can be swallowed into the stomach and from there absorbed into the bloodstream. You can minimize any effect from steroids left behind in your mouth in two ways. First, use a spacer tube with your steroid spray. (A spacer can not be used with budesonide dry powder inhaler.) Medicine that would otherwise land on your tongue and mouth stays in the spacer chamber. The part of the spray that passes through the spacer also tends to pass through your mouth and proceed down onto the bronchial tubes. Second, rinse your mouth with water after inhaling the steroid spray. Rinsing removes any medicine residue from your mouth. The portion of the medicine that helps your asthma remains undisturbed on your bronchial tubes.
So much for the theory; what about the actual experience with steroids in inhaled form? The current generation of steroid inhalers first began to be used in the mid 1960s. For more than three decades they have been prescribed for millions of people with asthma and other lung diseases worldwide. No serious long-term adverse effects have emerged. For adults, given in the usual doses, they do not cause degeneration (atrophy) of the normal tissues of the respiratory passageway. They do not predispose to lung infections. They do not cause cancer, diabetes, or high blood pressure.
We need to look more carefully at the two phrases used above: “for adults” and “in the usual doses.” Children’s bones may be sensitive to the very small amounts of steroids that can enter the bloodstream after inhalation. There is currently debate — and considerable on-going research — to determine whether in children inhaled steroids might slow bone growth and reduce a child’s ultimate height.
Also, when given in very large doses (many puffs from a high-concentration steroid inhaler), the amount of steroid medicine that spills over into the bloodstream can become significant. Although the effect is small, like a very small dose of prednisone, over the years this small effect can potentially add up to serious harmful effects. High doses of inhaled steroids taken for a long time can probably predispose to cataracts, glaucoma, and thinning of the skin and bones. As a result, your doctor will probably only have you take high doses of inhaled steroids as a means to avoid steroid tablets. And he/she will constantly work with you to attempt to reduce the dose of inhaled steroids to a more conventional and safer range.
Remember that not taking inhaled steroids for fear of side effects may have real consequences that are far worse than potential effects in the future; namely, asthma symptoms and risk of asthma attacks now. Severe asthma attacks are usually treated with steroid tablets, which all agree have the worst side effects.
How does this medication work? What will it do for me?
This medication contains two active ingredients: vilanterol and fluticasone. Vilanterol belongs to a group of medications called long acting bronchodilators (LABAs). These medications relax the muscles in the walls of the small air passages in the lung, keeping the air passage open and making it easier to breathe. Fluticasone belongs to a group of medications known as corticosteroids. Corticosteroids reduce inflammation in the lungs and help reduce the swelling and irritation in the walls of the small air passages in the lungs. This helps open the airways and improve breathing.
Fluticasone-vilanterol is used to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema. Fluticasone – vilanterol may also be used to treat asthma for certain people. It should only be used for people whose asthma is not well controlled using inhaled corticosteroids along with occasional use of bronchodilators.
It is important to remember that fluticasone – vilanterol is intended for long-term relief and is not intended for immediate relief. Inhalers that contain “reliever” medications with fast action (e.g., salbutamol, terbutaline) will still be needed while using this medication.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
100 µg/25 µg
This medication is provided in two strips of foil blisters. On one strip, each blister contains a white dry powder mixture of micronized fluticasone furoate equivalent to 100 µg and lactose monohydrate for inhalation. On the other strip, each blister contains a white dry powder mixture of micronized vilanterol trifenatate equivalent to 25 µg of vilanterol, magnesium stearate, and lactose monohydrate for inhalation administration.
200 µg/25 µg
This medication is provided in two strips of foil blisters. On one strip, each blister contains a white dry powder mixture of micronized fluticasone furoate equivalent to 200 µg and lactose monohydrate for inhalation. On the other strip, each blister contains a white dry powder mixture of micronized vilanterol trifenatate equivalent to 25 µg of vilanterol, magnesium stearate, and lactose monohydrate for inhalation administration.
How should I use this medication?
The recommended adult dose of fluticasone – vilanterol to treat COPD is one inhalation of 100 µg/25 µg once daily, at the same time every day.
When treating asthma, the recommended adult dose of fluticasone – vilanterol is one inhalation of 100 µg/25 µg or 200 µg/ 25 µg inhaled once daily, at the same time every day.
After inhaling the dose of medication, rinse your mouth with water and spit it out, to reduce the chances of developing thrush.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor.
Read the package insert or speak with your pharmacist for instructions on using the dispenser properly.
To make sure the medication remains effective, it is very important to use it regularly once a day, exactly as prescribed by your doctor, even when you are not experiencing symptoms of COPD or asthma. To prevent side effects, do not use this medication more often than prescribed.
If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not use this medication if you:
- are allergic to fluticasone, vilanterol, or any ingredients of the medication
- are allergic to lactose or milk protein
- are having an asthma attack with sudden shortness of breath or wheezing
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- back pain
- itchy, runny, or blocked nose
- joint pain
- muscle spasms
- pain and irritation in the back of the mouth
- voice hoarseness
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- bone pain or fractures (osteoporosis)
- flu-like symptoms (sudden lack of energy, fever, cough, sore throat) that includes rash, pins and needles sensation, worsening breathing problems
- increased blood pressure
- increased or irregular heartbeat
- signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat)
- sinus or throat infections
- signs of pneumonia (e.g., fever, chills, shortness of breath, cough)
- signs of too much corticosteroid (e.g., rapid weight gain, sweating, thinning skin, dry skin, muscle weakness)
- symptoms of cataracts (e.g., clouding in the eye, blurry vision, eye pain)
- symptoms of a common cold (e.g., sinus congestion, runny nose, sore throat, general feeling of being unwell)
- symptoms of COPD (e.g., shortness of breath, cough, chest discomfort, coughing up mucus)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- symptoms of glaucoma (increased pressure in the eye; e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
- symptoms of thrush (sore, raised patches in the mouth)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- sudden worsening or shortness of breath and wheezing immediately after using the medication
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Asthma-related deaths: When used for asthma treatment, another medication in the same class as vilanterol (LABAs) has been linked to an increase in asthma-related deaths. The use of inhaled corticosteroids, such as fluticasone, with LABAs appears to reduce the risk of serious asthma-related events. If you experience worsening symptoms or your “rescue” medications are not as effective as usual, contact your doctor or seek medical attention immediately.
Diabetes: This medication may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Eye problems: Fluticasone may increase the risk of developing cataracts or glaucoma. If you are at risk of developing either of these conditions, have your eyes checked by your doctor before starting long-term treatment with this medication. You should have your eyes monitored at regular intervals while using this medication.
Heart conditions: Vilanterol may cause increased blood pressure, rapid heart rate or irregular heart rhythms, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), high blood pressure or other heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infections: This medication, like other corticosteroids, may prevent the early signs of a serious infection from being noticed. Try to limit the amount of time you spend around others who have recently had infections such as chickenpox or measles. If you do come into contact with someone who has one of these infections, contact your doctor for advice.
Liver function: Liver disease or reduced liver function may cause fluticasone to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Oral hygiene: Fluticasone may cause thrush infection in the mouth and throat. Adequate oral hygiene is very important in minimizing the overgrowth of microorganisms such as candidiasis (thrush). To reduce the risk of infection, gargle with water after each use of this medication.
Osteoporosis: Long-term use of medications like fluticasone may increase your risk of developing osteoporosis. If you have osteoporosis or are at risk for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pneumonia: People using fluticasone-vilanterol to treat COPD may be at an increased risk of developing pneumonia. If you experience symptoms of pneumonia, such as fever, chills, shortness of breath, cough or chest pain, get medical attention as soon as possible.
Seizures: People with seizure disorders may be more likely to experience side effects of vilanterol. If you have a seizure disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Steroid medication use: If you have taken or are still taking oral steroid medications over the last several months, consult with your doctor before using this medication. In times of stress or during a severe asthma attack, your doctor may want you to start your oral steroid medication again.
Thyroid problems: People with thyroid conditions may be more likely to experience side effects of vilanterol. If you have an overactive thyroid gland, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Wheezing: This medication may cause the airways to spasm immediately after using the inhaler. If this happens, use your rescue inhaler as soon as possible to relieve the symptoms, then call your doctor as soon as possible.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if fluticasone – vilanterol passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: This medication is not intended for use by children. The safety and effectiveness of using this medication have not been established for children or people under the age of eighteen.
What other drugs could interact with this medication?
There may be an interaction between fluticasone – vilanterol and any of the following:
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- amphotericin B
- anaesthetics (e.g., halofantrine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- BCG vaccine
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
- decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
- diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, rosiglitazone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- fast-acting beta-2 agonists (e.g., salbutamol, fenoterol, terbutaline)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
- other long-acting beta-2 agonists (e.g., formoterol, indacaterol, salmeterol)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- protein kinase inhibitors (e.g., ceritinib, crizotinib, dasatinib, idelalasib, nilotinib, imatinib, sunitinib, )
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
- theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Breo-Ellipta
Breo Ellipta Side Effects
Generic Name: fluticasone / vilanterol
Medically reviewed by Drugs.com. Last updated on Feb 1, 2019.
- Side Effects
Note: This document contains side effect information about fluticasone / vilanterol. Some of the dosage forms listed on this page may not apply to the brand name Breo Ellipta.
For the Consumer
Applies to fluticasone / vilanterol: inhalation powder
Along with its needed effects, fluticasone/vilanterol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fluticasone/vilanterol:
- Body aches or pain
- difficulty with breathing
- ear congestion
- loss of voice
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain
- general feeling of discomfort or illness
- joint or muscle pain
- loss of appetite
- pain or tenderness around the eyes and cheekbones
- pounding in the ears
- slow or fast heartbeat
- tightness of the chest
- tingling of the hands or feet
- trouble sleeping
- troubled breathing
- unusual weight gain or loss
Incidence not known
- Fast, irregular, pounding, or racing heartbeat or pulse
- muscle spasms
- noisy breathing
Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone/vilanterol:
Symptoms of overdose
- Arm, back, or jaw pain
- chest discomfort
- chest heaviness
- decreased urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fruit-like breath odor
- increased hunger or thirst
- increased urination
- loss of appetite
- muscle cramps
- numbness or tingling in the hands, feet, or lips
- rapid, deep breathing
- shakiness in the legs, arms, hands, or feet
- stomach cramp or pain
- unexplained weight loss
Some side effects of fluticasone / vilanterol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Creamy white, curd-like patches in the mouth or throat
- difficulty with moving
- muscle stiffness
- pain when eating or swallowing
For Healthcare Professionals
Applies to fluticasone / vilanterol: inhalation powder
The most common adverse reactions are nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis.
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Extrasystoles
Common (1% to 10%): Diarrhea, oral candidiasis, abdominal pain
Common (1% to 10%): Back pain, arthralgia, fractures
Postmarketing reports: Muscle spasm
Common (1% to 10%): Headache, tremor
Common (1% to 10%): Influenza, pyrexia, peripheral edema
Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, oropharyngeal candidiasis, chronic obstructive pulmonary disease (COPD), pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, pharyngitis, oropharyngitis fungal
Frequency not reported: Paradoxical bronchospasm
Postmarketing reports: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria
Postmarketing reports: Hyperglycemia
1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
2. Cerner Multum, Inc. “Australian Product Information.” O 0
3. “Product Information. Breo Ellipta (fluticasone-vilanterol).” GlaxoSmithKline, Research Triangle Park, NC.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about Breo Ellipta (fluticasone / vilanterol)
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 153 Reviews
- Drug class: bronchodilator combinations
- FDA Alerts (1)
- FDA Approval History
- Breo Ellipta
- Breo Ellipta (Advanced Reading)
- Breo Ellipta (FDA)
Related treatment guides
- COPD, Maintenance
- Asthma, Maintenance
Breo Ellipta Facts
- Manufacturer:GlaxoSmithKline Plc. (GSK) and Theravance, Inc.
- Treatment For: Asthma, COPD
- FDA Approval:May 10, 2013
- Active Ingredients: vilanterol trifenate, fluticasone furoate
- Inactive Ingredients: magnesium stearate, lactose monohydrate
- Dosage: 100 mcg/ 25 mcg; 200 mcg/25 mcg
- Dosage Form: Inhalation powder
breo Ellipta used a once-daily maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD), including emphysema and/or chronic bronchitis. It is also approved to reduce flare-ups of COPD. Asthma is when the muscles surrounding airways become swollen, tight, and irritated. Symptoms include cough, wheezing, short of breath, and chest tightness. COPD is a long-term condition that tends to slowly get worse. Symptoms include coughing up mucus, chest discomfort, and shortness of breath.
Breo contains two active ingredients: a long-acting beta2-adrenergic agonist (LABA) known as vilanterol and an inhaled synthetic trifluorinated corticosteroid (fluticasone furoate). Vilanterol trifenate is a bronchodilator, which works to relax the muscles surrounding the smaller airways in the lungs. This makes it easier for air to move in and out of the lungs. When taken regularly, Breo helps the small airways to remain open. Fluticasone furoate is a corticosteroid, which is simply a steroid. It is used to reduce inflammation in the small airways in the lungs, easing breathing problems. These two medicines help control breathing difficulties when taken together regularly. Breo an anti-inflammatory agent and a smooth-muscle relaxant.
b reo Ellipta was approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD on May 10, 2013 and for the treatment of asthma in April 2015. The approval was based on 4 confirmatory trial enrolling 7,700 patients with moderate to severe COPD. The trials were conducted 6- and 12-months’ duration, where there were three 12-week active comparator trials, and shorter durations of dose-ranging trials. The FDA’s advisory committee had no issue recommending the drug, voting 9-4 in support for its administration in long-term maintenance and exacerbation reduction of COPD. Some panelists did raise concerns that the LABA component- vilanterol- provided great clinical benefits and also increased the risk of bone fractures (in2%) and pneumonia (in 3%), and the high dropout rate in the trials. The panelists agreed that once-daily use of Breo Ellipta may improve medication adherence, although this wasn’t tested in any of the trials.
Uniqueness of Product
the Breo Ellipta powder increases airflow. In in vivo and in vitro models, fluticasone furoate blocked pro-inflammatory transcription factors (such as nuclear factor-kappa light enhancer of cells B), inhibited lung eosinophilia induced by antigens, and activated the glucocorticoid response element in sensitized rats. In in vitro tests, fluticasone furoate shows a binding similarity to the human glucocorticoid receptors, which is 1.7 times that of fluticasone propionate and 29.9 times that of dexamethasone. The functional selectivity of vilanterol was similar to salmeterol xinafoate.
Beta1-receptors are predominant in the heart whereas Beta2-receptors are adrenergic receptors predominant in bronchial smooth muscle. Beta2-receptors make up 10 to 50 percent of the total number of predominant beta-adrenergic receptors.
The pharmacological effects of beta2-adrenoceptor agonists play a major role in the stimulation of intracellular adenyl cyclase, the enzyme that acts as a catalyst in the conversion of adenosine triphosphate to cyclic adenosine monophosphate (cAMP). When the levels of cAMP increase, the bronchial muscle relax and the release of mediators of hypersensitivity from cells is inhibited.
It’s not known the mechanism by which COPD symptoms are affected by fluticasone furoate. Because the drug is a corticosteroid, it can produce various effects on many cell types (such as lymphocytes, neutrophils, eosinophil, mast cells, and macrophages) and mediators (such as eicosanoids, histamine, cytokines, and leukotriene) involved in inflammation.
Breo Dosage and Administration
breo is a powdered inhaler containing a white dry powder mixture of micronized vilanterol trifenate and micronized fluticasone furoate. The starting dose of vilanterol-fluticasone for patients 18 years or older depends of the severity of the condition. The recommended dose of Breo Ellipta for patients with COPD and asthma is 100 mcg of fluticasone furoate and 25 mcg of vilanterol once daily as one oral inhalation. Conversely, the doctor may recommend one inhalation 200 mg fluticasone furoate and 25 mcg of vilanterol, which is the higher strength Breo inhaler. The starting dosage for patients with asthma is based on the severity of the condition. For patients previously treated with mid-to-high dose of treatment containing a corticosteroid, Breo Ellipta 200/25 mcg should be considered.
Conversely, Breo 100/25 should be considered for patients previously treated with low-to-mid dose of treatment containing corticosteroid. Breo Ellipta 200/25 may provide additional improvement in asthma control for patients who do not adequately respond to the drug. A doctor will assess your condition at regular intervals so as to ensure that the patient is getting the dose most suitable for the severity of their asthma. The higher strength Breo dose is not suitable for the treatment of COPD.
Breo should be taken at the same time every day and after inhalation, patients are advised to rinse their mouth without swallowing in order to reduce the risk of fungal infection in the mouth or throat (oropharyngeal candidiasis). No dosage adjustments are needed for patients with renal or hepatic impairment or geriatric patients. The dose of medication that a person needs may vary based on the body weight, other medication taken, and other medical conditions. If your doctor recommends a dose that’s different from the one stated here, you should not change how you’re taking the medication without medical advice. Use Breo for as long as your doctor recommends and don’t stop without consulting your doctor, even if you feel better.
Breo Ellipta should not be used as a rescue therapy to relieve acute bronchospasm episodes.
Side Effects Possible with Breo
along with its needed effects, a medication may cause an unwanted response when taken in normal doses. Side effects can be temporary or permanent, mild or severe. Although not all of the side effects listed below are experienced by everyone who takes Breo Ellipta, if they do occur, they may need immediate medical attention. It’s important to discuss the risks and benefits of Breo with your physician.
Common side effects include:
- back pain
- muscle spasms
- voice changes and hoarseness
- difficulty with breathing
- runny, itchy, or blocked nose
- sudden lack of energy
- chest discomfort
Contact your doctor as soon as possible if you experience any of the following side effects:
- increased blood pressure
- signs of decreased adrenal function (e.g. low blood pressure, vomiting, nausea, tiredness, or weakness)
- signs of pneumonia (such as shortness of breath, chills, cough, fever)
- signs of electrolyte imbalance (e.g., weakness, muscle pain or cramps, irregular heartbeat)
- sinus or throat infection
- bone pains or fractures (osteoporosis)
- joint pain
- shakiness in the arms, hands, legs, or feet
- irregular or increased heartbeat
- flu-like symptoms (e.g. fever, sore throat, sudden lack of energy, fever) that includes pins and needles sensation, rash, breathing problems, worsening breathing problems
- symptoms of cataracts (e.g., eye pain, blurry vision, clouding in the eye)
- signs of too much corticosteroid (sweating, dry skin, thinning skin, rapid weight gain, muscle weakness)
- symptoms of high blood sugar (e.g. increased thirst, poor wound healing, fruity breath odor, infections, unexplained weight loss, frequent urination)
- symptoms of thrush or oral candidiasis (raised, sore patches in the mouth)
- symptoms of worsening COPS (e.g. chest discomfort, shortness of breath, coughing up mucus)
- symptoms of glaucoma or increased pressure in the eye (e.g. seeing halos of bright colors around lights, eye pain or discomfort, blurred vision, red eyes)
- allergic reaction such as swelling on the face or throat
- wheezing or sudden shortness of breath immediately after using Breo
These are not all the possible side effects of Breo. Some people may experience other side effects not listed above. While most of these side effects don’t happen very often, they could lead to serious problems if you do not seek medical attention.
A total of 807 drugs are known to interact with Breo:
- 19 minor drug interactions
- 723 moderate drug interactions, and
- 65 major interactions
Caution should be taken when prescribing Breo with strong CYP3A4 inhibitors and long-term treatments with ketoconazole (Nizoral). Breo may interact with the following drugs:
Drug interactions may change how the medication works and may also increase the risk for life-threatening side effects. For instance, medications such as azole antifungals, HIV protease inhibitors, boceprevir, among others can affect the removal of fluticasone from the body, which may consequently affect how fluticasone functions. Interactions may also result in increased cardiovascular and systemic corticosteroid adverse effects. A class of medicines known as “beta-blockers” used to treat a heart condition or high blood pressure should be avoided because they block the pulmonary effect of vilanterol and may also produce severe bronchospasm in patients with asthma or COPD.
Not all possible drug interactions are listed above. Patients are advised to keep a list of all products they use (including herbal products and prescription/non-prescription drugs) and share it with their doctor. In addition, one should not start, change, or stop the dosage of any medicine without the approval of a doctor.
Warnings and Precautions
- Deterioration of Disease
Breo should not be administered to patients during potentially threatening or rapidly deteriorating episodes of asthma or COPD. There’s no study for Breo in individuals with acutely deteriorating asthma or COPD but initiation of an inhaled short-acting beta2-agonist in this setting is not appropriate. When prescribing Breo, physicians should prescribe a short-acting beta2-agonist and provide instructions on how it should be used.
A patient’s condition may worsen over a few hours, several days or longer. If the short-acting beta2-agonist is not as effective as it should be or Breo no longer controls the symptoms associated with bronchoconstriction, or the patient needs more inhalations than usual, these may be signs that the disease is deteriorating. In such a case, there’s need for immediate reevaluation of the patient and the COPD regimen. Increasing the daily dose of Breo Ellipta 100/25 in the case of COPD is not suitable.
If there’s need to increase of inhaled short-acting beta2-agonist, that’s a sign of deteriorating asthma. In such a setting, an immediate reevaluation of the patient is required along reassessment of the treatment regimen, considering the possible need for initiating systemic corticosteroids, adding additional ICS, or replacing the current strength of Breo with a higher strength.
In clinical trials, an increased incidence of pneumonia was observed in patients with COPD receiving the Breo 100/25 dose. Also, there was an increase in cases of pneumonia resulting in hospitalization and some were fatal. The symptoms of COPD exacerbations overlap with clinical features of pulmonary infections and for this reason, doctors should remain vigilant for the possible development of pneumonia.
In 3,255 subjects with COPD who had an exacerbation of COPD, there was a higher incidence of pneumonia in those receiving 200 mcg/25 mcg or 100 mcg/25 mcg than in subjects receiving 25 mcg vilanterol. Also, there were no fatal cases of pneumonia in subjects taking Breo Ellipta 50 mcg/25 mcg. There were 7 pneumonia-related fatalities in patients taking Breo 200/25 and in 1 subject receiving Breo 100/25.
Individuals taking immunosuppressive drugs are more susceptible to infections when compared to healthy persons. Measles and chickenpox, for instance, can have severe or fatal effects in individuals using corticosteroids. Physicians should be cautious to avoid exposure. The risk of developing a disseminated infection caused by the route, dose, and duration of corticosteroids is not known. If a patient is exposed to prophylaxis and chickenpox with pooled immune globulin may be indicated. Inhaled corticosteroids should be cautiously used if the patient is in quiescent or active tuberculosis infections of the respiratory tract; bacterial, systemic, parasitic, or viral infection; or ocular herpes simplex.
- Reduced Bone Density
Long-term administration of inhaled corticosteroids has been linked to result in decreased bone density (BMD). Patients with major risk factors such as family history of osteoporosis, tobacco use, poor nutrition, prolonged immobilization, advanced age and prolonged use of drugs known to reduce bone mass should be treated and monitored with established standards of care.
And since individuals with COPD usually have multiple risk factors for reduced bone density, an assessment is recommended before and after Breo Ellipta is used. Conversely, if Breo Ellipta is still considered as beneficial for the COPD therapy but there’s a significant reduction of bone mineral density, a medication to prevent or treat osteoporosis should be considered. In a 12-month clinical trial in 3,255 individuals with COPD, 2% of patients receiving Breo Ellipta 200/25, 100/25, and 50/25 had bone fractures compared with less than 1% of individuals receiving 25 mcg vilanterol alone.
- Cardiovascular Effects
Like other beta2-agonists, vilanterol can produce significant cardiovascular effects. This can be marked by an increase in systolic or diastolic blood pressure, pulse rate, as well as cardiac arrhythmias such as extrasystoles and supraventricular tachycardia. Breo Ellipta may need to be discontinued if such effects occur. Furthermore, beta-agonists produce electrocardiographic changes such as the prolongation of the corrected QTc interval, flattening of the T wave, and ST-segment depression. Large doses or excessive use of Breo Ellipta has been associated with prolongation of the QTc interval, which can result in ventricular arrhythmias. As such, caution should be taken if patients have cardiovascular disorders, particularly cardiac arrhythmias, coronary insufficiency, and hypertension.
- Ocular Problems
Patients with COPD receiving inhaled corticosteroids for a long-term are at risk of cataracts, glaucoma, and increased intraocular pressure. Close monitoring is warranted in patients with a history of ocular changes or a change in vision.
The administration of Breo Ellipta may elicit hypersensitive reactions. Patients with severe milk protein allergy may get anaphylactic reactions after inhalation of other powder products containing lactose. As such, Breo should not be recommended for patients with severe milk protein allergy.
- Paradoxical Bronchospasm
Breo Ellipta, as with other inhaled products, can result in paradoxical bronchospasm, which may be fatal. Patients should use inhaled short-acting bronchodilator if they get bronchospasm. Also, the use of Breo Ellipta should be immediately stopped and an alternative treatment used.
- Adrenal Suppression and Hyperadrenocorticism
Inhaled fluticasone furoate can be systemically active as it’s absorbed into the circulation system. The effects of the recommended therapeutic dose of Breo are observed on the HPA axis, but exceeding dosage or taking the drug with a strong cytochrome inhibitor may cause HPA dysfunction. And since sensitive patients face a risk of significant absorption of inhaled corticosteroids, patients receiving Breo Ellipta should be closely monitored to see is there are systemic corticosteroid effects such as adrenal suppression and hyperadrenocorticism. Breo Ellipta dosage should be reduced slowly if these effects occur with accepted systemic corticosteroids reduction procedures, and other alternative therapies for COPD symptoms should be considered.
- Oral Candidiasis
Like with other inhaled corticosteroids, the use of fluticasone furoate/vilanterol may result in localized infections of the mouth and throat. While the treatment of Breo Ellipta continues, Candida albicans should be treated with appropriate anti-fungal therapy. In some cases, it might be necessary for inhaler therapy to be interrupted. Patients are advised to rinse their mouth after inhalation to reduce the risk of oral candidiasis.
- Hyperglycemia and Hypokalemia
Breo Ellipta may produce hypokalemia, which may result in adverse cardiovascular effects. Beta-adrenergic agonists may lead to a decrease in potassium and may produce transient hyperglycemia in some patients.
the use of Breo Ellipta is contraindicated in demonstrated hypersensitivity to vilanterol, fluticasone furoate, or any of the excipients, severe hypersensitivity to milk proteins as well as in the primary treatment of acute episodes of asthma or COPD where intensive measures are required.
Breo Ellipta Black Box Warning
data from large placebo-controlled trials in asthmatic patients suggested that LABAs may increase the risk of asthma-related deaths. However, it is not known whether LABAs increase the rate of death in patients with COPD. In a trial comparing salmeterol (another LABA) with placebo, asthma-related deaths increased with each usual asthma therapy. The finding is a class effect of LABAs, vilanterol included. However, a review of four large clinical safety trials by the FDA indicates that the use of long-acting beta-agonists for the treatment of asthma in combination with inhaled corticosteroids doesn’t lead to more serious asthma-related side effects that when inhaled corticosteroids are administered exclusively.
In December 2018, the boxed warning about asthma-related deaths was removed from the Breo Ellipta label and other medicines that contain both LABA and ICS. Trials that led to this decision showed that when used with ICS, LABAs did not significantly increase the risk of hospitalizations, the need to insert an intubation, or asthma-related deaths, when compared to the use of ICS alone. The FDA stated that the risk of asthma-related deaths was associated with the use of LABAs to treat asthma without incorporating ICS to treat lung inflammation. Even so, a Warning and Precaution section will be retained on the Breo Ellipta label to warn patients of the risks of asthma-related deaths.
Finding Help for a Breo Lawsuit Near Me
if you took Breo Ellipta and suffered serious infections, cancer, intestinal perforations, tuberculosis, or any other serious side effect, you may be entitled to compensation. Consumer Alert Now helps connect individuals from all over the United States with seasoned attorneys. We are committed to keeping people safe from potentially harmful drugs and support people in pursuit of due justice for their injuries, damages, suffering, and deadly side effects of prescription medications. We work with leaders in the mass tort field to ensure that affected individuals get the help and justice they deserve. All our services are free and you don’t have to be a member to get help. Call us today at (800) 511-0747 or fill out the free case review form to get connected to the appropriate legal professional.