- Titration May Reduce Nausea from Anti-Smoking Drug
- Whitewashing a black box warning: The Chantix story that didn’t get told
- Chantix Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- Further information
- More about Chantix (varenicline)
- What is Chantix
- How Does Chantix Work
- Why Side Effects Occur?
- How to Minimize the Risk of Chantix Side Effects
- Zyban Vs Chantix
- Smokers deserve better than Chantix. Much better.
- Increase Penis Size Using Herbs | High-Quality [Webmd] Chantix Side Effects Erectile Dysfunction Boost Testosterone Levels
Titration May Reduce Nausea from Anti-Smoking Drug
FARMINGTON, Conn., Aug. 15 — Many patients taking Chantix (varenicline tartrate) to help kick the smoking habit could be spared the side effect of nausea if introduced to the drug gradually, according to researchers here.
Titrating the dose of Chantix during the first week of treatment led to a drop of six to seven percentage points in the proportion of patients who became nauseated, said Cheryl Oncken, M.D., of the University of Connecticut Health Center here.
Nausea is a common side effect that sometimes causes patients to discontinue treatment, Dr. Oncken and colleagues reported in the Aug. 14-28 issue of the Archives of Internal Medicine. The study was supported by Pfizer, which makes Chantix. Pfizer was involved in all elements of this study, including, but not limited to, the study design and monitoring.
- Be aware that this study suggests that titrating doses of Chantix over the course of the first week of therapy may help prevent nausea in some patients who are trying to quit smoking.
The study included nearly 650 patients who smoked an average of 21 cigarettes per day for an average of 25 years. Participants were randomized to a placebo group or one of four treatment groups: 0.5 mg Chantix non-titrated, 0.5 mg Chantix titrated, 1.0 mg Chantix non-titrated, 1.0 mg Chantix titrated.
In both titrated groups, the dose started out at 0.5 mg once daily. Over the course of seven days, the dose was gradually escalated to the full target dose, given twice-daily. The study followed participants as they attempted to quit smoking for 12 weeks, which is the usual course of treatment with Chantix, and then for an additional 40 weeks for a total follow-up of one year.
During treatment, 42% of the non-titrated 1.0 mg group became nauseated, versus 34% of the 1.0 mg titrated group (P not given). About 15% of the placebo group had nausea (P
In addition, 23% of the non-titrated 0.5 mg group experienced nausea versus 16% of the titrated 0.5 mg group (P not given). Neither of these nausea rates differed significantly from the placebo rate (P=0.12 for the non-titrated group; P=0.86 for the titrated group).
Although the researchers did not report P values for the different nausea rates in the titrated versus non-titrated dosage groups, they concluded that “titration during the first week of treatment appeared to reduce the incidence of nausea.”
The smoking abstinence rate through week 52 of the study, confirmed by breath measurements of carbon monoxide, was 4% for the placebo group, 22% for all patients receiving 1.0 mg twice daily (PP
Chantix was approved by the FDA last May 11. The drug is thought to be an a4ÃÅ¸2 nicotine receptor antagonist, blocking the rewarding effects of nicotine. But the drug is also believed to be a partial agonist to this receptor, stimulating enough dopamine release to reduce nicotine withdrawal cravings.
In an accompanying editorial in the Archives, Bankole A. Johnson, D.Sc., M.D., Ph.D., of the University of Virginia called Chantix a welcome alternative to nicotine replacement therapy and Zyban (bupropion) for doctors trying to help patients quit smoking.
“Varenicline was well-tolerated and promises to be more effective in clinical practice than bupropion,” Dr. Johnson said. “Now, a smoker who wants help to quit no longer has a legitimate excuse to delay seeking treatment.”
Four of the authors reported a variety of financial relationships with Pfizer and an additional four authors are employees of Pfizer.
Archives of Internal Medicine
Source Reference: Oncken C et al. “Efficacy and safety of the novel selective nicotinic acetycholine receptor partial agonist, varenicline, for smoking cessation.” Arch Intern Med 2006; 166:1571-1577.
Archives of Internal Medicine
Source Reference: Johnson B. “New weapon to curb smoking: No more excuses to delay treatment.” Arch Intern Med 2006; 166:1547-1550.
Whitewashing a black box warning: The Chantix story that didn’t get told
Almost every drug that has been removed from the U.S. market over the past 20 years has been preceded by the dreaded “black box warning,” which appears on a prescription drug’s label and “is designed to call attention to serious or life-threatening risks.”
But in mid December, in an unprecedented move, the FDA removed the black box warning from Pfizer’s smoking cessation drug Chantix (varenicline). While this didn’t come as much of a surprise to some, it was a newsworthy event, receiving coverage by Reuters, The Wall Street Journal, STAT, Pharma Times, Philadelphia Business Journal, and Medscape.
The decision to remove the black box warning had its roots in a study known as the EAGLES trial, which was mandated by the FDA and designed to establish the neuropsychiatric safety and efficacy of varenicline, buproprion and nicotine patches in smokers with or without psychiatric disorders. Pfizer maintained that this trial confirmed Chantix’s superiority and safety, yet the trial was highly criticized by some observers. Those objections received little attention from some news outlets that covered the label update.
Can we trust the EAGLES trial? Independent watchdog says ‘No’
As a randomized placebo-controlled trial sitting at the pinnacle of the evidence pyramid, EAGLES might be expected to settle the question of Chantix’s safety. Not so, according to Thomas Moore, a senior scientist with the Institute for Safe Medication Practices, an independent nonprofit group that studies drug safety. ISMP released numerous reports detailing Chantix adverse effects, including one in 2014 that analyzed Chantiz-related adverse events from 2007 through most of 2013. It found that Chantix had more cases of suicidal thoughts, self-harm, and homicidal thoughts than any other drug, by a more than three-fold margin. Moore believes that the Chantix warnings needed to be strengthened, not removed.
About the EAGLES trial, he told STAT: “With eight different treatment arms, the number of patients in each may not be enough to capture the severe psychiatric side effects for which the drug is known.”
The ISMP went further in describing EAGLES’s design problems in a statement urging the FDA not to remove the black box warning: “The study was powered to detect a moderate or severe drug event in at least 4% of the patients in any treatment group, a very large serious adverse drug
effect of any kind, for any drug, in any setting.” Suicidal thoughts and violent behaviors are thought to occur in much fewer than 4% of medication users, the ISMP statement noted. “Given an expected event rate measured in few cases per 1,000 it was a certain recipe for failure to design a safety trial capable of detecting an effect frequency of 40 per 1,000 cases (or 4%), and relying on an unvalidated measurement scale never used as a clinical trial endpoint. This trial was underpowered by an order of magnitude.”
Advocate believes victims were ‘silenced’ by settlement
Those concerns were echoed by Kim Witczak who sits on the the FDA Psychopharmacologic Drugs Advisory Committee as a consumer representative. As a long-time drug safety advocate, she intended to participate at the committee hearings on the safety of Chantix but was recused from this meeting because of a previous lawsuit against Pfizer. Witczak attributes her husband’s suicide in 2003 to the Pfizer antidepressant Zoloft.
Over the phone from Los Angeles, she told me she attended the Washington meeting on her own dime and expressed her concerns over what the EAGLES trial did and did not show.
She told the committee she looked at a small sample of 100 patients involved in the study, and in that sample there were two overdose cases and a patient who died in a car accident. None of these was coded as suicide, one of the potential adverse effects related to Chantix. Were those deaths appropriately coded? In Witczaks’s opinion, like that of Thomas Moore, the EAGLES study was funded by manufacturers and required an in-depth, independent review of all cases of adverse events in order to be certain. But this didn’t happen.
Witczak views FDA committee hearings as highly political events. In the case of Chantix, she says, patient groups dedicated to quitting smoking gave testimony begging for removal of the black box even though those groups are funded by the manufacturers of smoking cessation drugs.
In her mind, the removal of the warning “will be spun as safe, that the risk of smoking is greater than the risk of the drug.” But this characterization ignores the experiences of 2,700 people who took legal action against Pfizer, Witczak says. Many of those who attempted suicide–which they blamed on the drug–settled in a legal action against Pfizer and the details of those cases remain sealed (though details would have been made available to the FDA). For Witczak, “the 2,700 victims before the black box warning are all silenced.”
Dissenting voices get little play; Pfizer widely quoted
The boxed warning that was added to the Chantix label in 2009 and removed in 2016.
Many stories on the FDA decision still describe serious concerns about the drug. The Philadelphia Business Journal noted: “Chantix’s updated label will still carry a warning of potential adverse events such as psychosis, hallucinations, paranoia and anxiety and other neuropsychiatric problems. The difference is those events will not be highlighted in a ‘black box’ warning, the FDA’s sternest warning for an approved medicine.”
However, few stories gave adequate weight to the voices of expert, independent groups like U.S. Public Citizen, which was so concerned about Chantix’s dangers it launched a petition in 2014 asking the FDA for stronger warnings on Chantix. Other groups, including Consumer Reports, the National Center for Health Research and the National Physicians Alliance, also reviewed the evidence of Chantix and asked for additional side effects be added to the black-box warning including “risks of psychotic symptoms, blackouts, convulsions and impaired vision as well as unexplained hostility, anger and aggression toward others.”
In addition, few of the most recent stories noted the contentious nature of the September 2016 FDA advisory committee meeting, nor discussed the concerns of dissenting panel members. Ten members of the 19-member panel voted in favor of removing the black box, four recommended a language change and five recommended the strengthening of the label. While those details were missing, many stories quoted the Chief Medical Officer of Pfizer, who said in a news release that “The totality of available scientific evidence, including the outcomes of EAGLES, supports the safety and efficacy of CHANTIX.”
A precedent for future rollbacks? Journalists should be vigilant
Critics fear that this is just a first step toward additional black box rollbacks supported by industry based on potentially biased evidence. For example, antidepressants have carried a black box warning on increased risks of suicide in young people since 2004. Studies questioning that warning, some of which have been conducted by researchers tied to the pharmaceutical industry, have been appearing ever since. FDA officials have been quick to point out the many flaws in these analyses, but one wonders how consistent that position will remain in the face of a changing U.S. administration with possibly radically different regulatory priorities.
Chantix Side Effects
Generic Name: varenicline
Medically reviewed by Drugs.com. Last updated on Nov 25, 2018.
- Side Effects
Note: This document contains side effect information about varenicline. Some of the dosage forms listed on this page may not apply to the brand name Chantix.
Common side effects of Chantix include: insomnia, nausea, and abnormal dreams. Other side effects include: constipation, dyspepsia, sleep disorder, vomiting, and flatulence. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to varenicline: oral tablet
Along with its needed effects, varenicline (the active ingredient contained in Chantix) 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 varenicline:
- Difficult or labored breathing
- tightness in the chest
Incidence not known
- behavior changes
- feeling sad or empty
- feelings of panic
- irregular heartbeats
- loss of interest or pleasure
- mood swings
- seeing, hearing, or feeling things that are not there
- thoughts of killing oneself
Some side effects of varenicline 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:
- Abnormal dreams
- bloated or full feeling
- change in taste
- difficulty having a bowel movement (stool)
- dry mouth
- excess air or gas in the stomach or intestines
- general feeling of discomfort or illness
- lack or loss of strength
- loss of taste
- passing gas
- stomach pain
- trouble sleeping
- unusual tiredness or weakness
- Acid or sour stomach
- body aches or pain
- decreased appetite
- ear congestion
- increased appetite
- itching skin or rash
- loss of appetite
- loss of voice
- sleepiness or unusual drowsiness
- sneezing or sore throat
- stomach discomfort or upset
- stuffy or runny nose
- trouble concentrating
- unusual drowsiness, dullness, or feeling of sluggishness
For Healthcare Professionals
Applies to varenicline: oral tablet
The most commonly reported side effects included nausea, headache, insomnia, and abnormal dreams.
Rare (less than 0.1%): Abnormal behavior, bradyphrenia, disorientation, dysphoria, euphoric mood, psychosis, somnambulism
Frequency not reported: Early morning awakening, initial insomnia, neuropsychiatric adverse events, suicidality
Postmarketing reports: Aggressive behavior, changes in behavior, changes in thinking, delusions, completed suicide, exacerbation of underlying psychiatric illness, homicidal ideation, nicotine withdrawal symptoms, panic, suicide, suicide attempt
Very common (10% or more): Nausea (up to 40%), vomiting (up to 11%)
Common (1% to 10%): Abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastroenteritis, gastroesophageal reflux disease, toothache
Uncommon (0.1% to 1%): Aphthous stomatitis, change of bowel habit, dysphagia, eructation, gastritis, gastrointestinal hemorrhage, gingival pain, hematochezia, mouth ulceration
Very common (10% or more): Headache (up to 19%)
Common (1% to 10%): Disturbance in attention, dizziness, dysgeusia, lethargy, somnolence
Uncommon (0.1% to 1%): Amnesia, convulsion, hypoesthesia, hypogeusia, migraine, parosmia, seizure, syncope, tremor, vertigo
Rare (less than 0.1%): Balance disorder, cerebrovascular accident, coordination abnormal, circadian rhythm sleep disorder, dysarthria, hypertonia, mental impairment, multiple sclerosis, nystagmus, psychomotor hyperactivity, psychomotor skills impaired, restless legs syndrome, scotoma, sensory disturbance, transient ischemic attack, VIIth nerve paralysis, visual field defect
Frequency not reported: Transient loss of consciousness
Postmarketing reports: Blackouts, hemorrhagic cerebrovascular event, ischemic cerebrovascular event, loss of consciousness
Very common (10% or more): Nasopharyngitis (up to 11%)
Common (1% to 10%): Bronchitis, cough, dyspnea, oropharyngeal pain, respiratory disorders, rhinorrhea, upper respiratory tract disorder, upper respiratory tract infection
Uncommon (0.1% to 1%): Allergic rhinitis, asthma, dysphonia, epistaxis, respiratory tract congestion, sinus congestion, throat irritation, upper- airway cough syndrome, upper respiratory tract inflammation
Rare (less than 0.1%): Laryngeal pain, pleurisy, pulmonary embolism, snoring
Very common (10% or more): Application site pruritus (up to 11%)
Common (1% to 10%): Angina pectoris, chest pain, hospitalization for angina pectoris, hypertension, need for coronary revascularization, new diagnosis of peripheral vascular disease (PVD)/admission for a PVD procedure, nonfatal myocardial infarction, peripheral edema
Uncommon (0.1% to 1%): Blood pressure increased, chest discomfort, ECG abnormal, edema, heart rate increased, hospitalization for angina pectoris, hot flush, myocardial infarction, palpitations, tachycardia
Rare (less than 0.1%): Acute coronary syndrome, arrhythmia, atrial fibrillation, bradycardia, cardiac flutter, cor pulmonale, coronary artery disease, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, thrombosis, ventricular extrasystoles
Frequency not reported: Cardiovascular events
Common (1% to 10%): Anorexia, decreased appetite, increased appetite, weight increased
Uncommon (0.1% to 1%): Diabetes mellitus, hyperglycemia, hypoglycemia
Rare (less than 0.1%): Blood calcium decreased, C-reactive protein increased, hyperlipidemia, hypokalemia, polydipsia
Common (1% to 10%): Arthralgia, back pain, myalgia, pain in extremity
Uncommon (0.1% to 1%): arthritis, muscle cramp, muscle spasms, musculoskeletal chest pain, musculoskeletal pain
Rare (less than 0.1%): costochondritis, joint stiffness, muscle enzyme increased, myositis, osteoporosis
Common (1% to 10%): Asthenia, fatigue, malaise
Uncommon (0.1% to 1%): Chills, pyrexia, tinnitus
Rare (less than 0.1%): Cyst, deafness, feeling cold, Meniere’s disease
Frequency not reported: Accidental injury, interaction with alcohol
Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Acne, dry skin, eczema, erythema, hyperhidrosis, night sweats, urticaria
Rare (less than 0.1%): Erythema multiforme, photosensitivity, psoriasis, severe cutaneous reactions, Stevens-Johnson Syndrome
Frequency not reported: Serious skin reactions
Common (1% to 10%): Menstrual disorder
Uncommon (0.1% to 1%): Erectile dysfunction, menorrhagia, nocturia, pollakiuria, polyuria, urine abnormality
Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Fungal infection, influenza like illness, viral infection
Common (1% to 10%): Liver function test abnormal
Uncommon (0.1% to 1%): Conjunctivitis, eye pain, eye irritation, vision blurred, visual disturbance
Rare (less than 0.1%): Blindness transient, cataract subcapsular, dry eye, lacrimation increased, mydriasis, myopia, night blindness, ocular vascular disorder, photophobia, scleral discoloration, vitreous floaters
Uncommon (0.1% to 1%): Anemia, lymphadenopathy
Rare (less than 0.1%): Leukocytosis, platelet count decreased, splenomegaly, thrombocytopenia
Uncommon (0.1% to 1%): Thyroid gland disorders
Rare (less than 0.1%): Acute renal failure, nephrolithiasis, urine analysis abnormal
Rare (less than 0.1%): Angioedema
Frequency not reported: Hypersensitivity reactions
1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
2. Cerner Multum, Inc. “Australian Product Information.” O 0
3. “Product Information. Chantix (varenicline).” Pfizer U.S. Pharmaceuticals Group, New York, NY.
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.
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Related treatment guides
- Smoking Cessation
It is okay if you do not succeed at your attempt to quit and have a cigarette. You can still continue your quit attempt and keep using this medicine as directed. Just throw away your cigarettes and get back to your quit plan.
Talk to your health care provider before using other treatments to quit smoking. Using this medicine with other treatments to quit smoking may increase the risk for side effects compared to using a treatment alone.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
Decrease the number of alcoholic beverages that you drink during treatment with this medicine until you know if this medicine affects your ability to tolerate alcohol. Some people have experienced increased drunkenness (intoxication), unusual or sometimes aggressive behavior, or no memory of things that have happened (amnesia) during treatment with this medicine.
Sleepwalking can happen during treatment with this medicine, and can sometimes lead to behavior that is harmful to you, other people, or property. Stop taking this medicine and tell your doctor if you start sleepwalking or have other unusual sleep-related activity.
After taking this medicine, you may get up out of bed and do an activity that you do not know you are doing. The next morning, you may have no memory of this. Activities include driving a car (“sleep-driving”), making and eating food, talking on the phone, sexual activity, and sleep-walking. Serious injuries have occurred. Stop the medicine and call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you have used alcohol that evening. Do not take it if you have taken another medicine for sleep. The risk of doing these sleep-related activities is higher.
Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, call your health care professional.
If you have diabetes and you quit smoking, the effects of insulin may be increased and you may need to reduce your insulin dose. Check with your doctor or health care professional about how you should adjust your insulin dose.
What is Chantix
Approved by FDA in May, 2006 as a smoking cessation aid, Chantix is a nicotine antagonistic drug (Varenicline Tartrate). Manufactured by the pharmacy giant Pfizer, the drug has been proven to be more effective than nicotine replacement therapy (NRT) such as nicotine patches and gums, as well as other drugs to help kick nicotine addiction.
Chantix is a prescription tablet, taken orally. In most cases, it is recommended that the patient takes Chantix for 12 weeks as a part of a stop-smoking plan. For best results, Chantix also offers an exclusive GetQuit Plan to provide support and follow-up throughout the quitting process. Many studies have also shown that combining prescription stop smoking aids with counseling increase the rate of smokers that remain cigarette abstinent for longer than a year. Many health insurance plans now cover Chantix and other prescription smoking cessation aids, easing the burden of cost.
How Does Chantix Work
To understand how Chantix works, let’s first see how nicotine addiction works:
When the user takes nicotine, it instantly gets absorbed by the blood and is transported to almost all the organs of the body, this happens both through smoking and vaping the best vapes. The biggest impact it has is on the brain, as it acts as a stimulant to make the brain release neurotransmitter dopamine and create a happy “buzz” that gives the user a pleasurable feeling of high, which doesn’t last long. In other words, nicotine activates a reward pathway in brain circuitry by the release of dopamine. Moreover, the human body is resistant to nicotine. Nicotine user wants to enjoy the feeling of high again and again, but as the body gets used to nicotine, higher amount and frequency is required to achieve the desired sensation.
Long-term use of nicotine, with repeated cycles of reward response, gradually leads to addiction. Extreme withdrawal symptoms can ensue when your body stops getting nicotine. Once you get addicted to nicotine, it becomes extremely hard to kick. In fact, many health experts consider it to be more addictive than heroin and cocaine. While nicotine is the addictive compound in the tobacco products, but it’s accompanied by countless other harmful chemicals such as tar and hundreds of carcinogens. This is where you need certain aid to get you nicotine fix without the hazardous chemicals, some of which can even be found in vape tanks.
What really makes Chantix effective is its two-pronged strategy to help you gradually kick your addiction. Firstly, it offers your brain a nicotine-like relief by stimulating nicotine receptors just like cigarettes do, so that your body can cope with nicotine withdrawal symptoms. Secondly, it decreases the pleasurable effects of the buzz or high by cutting down the reward response pathways. This makes your endeavor to smoking cessation extremely easy as you’ll neither have to deal with the withdrawals nor will lighting up a cigarette feel as good as it used to be because of the roadblocks by Chantix.
Chantix Success Rate
According to a study conducted by Pfizer, Chantix has a 44% success rate. According to the study, 44% of the subjects were abstinent by week 12 of the study, while only 18% of the placebo (sugar pills) users were abstinent. Talking impartially, this number is highly exaggerated as the subjects followed a 12-week cessation program and, at the time these stats were gathered, were still under the influence of the drug. After one year, the number dropped to about 25% of the subjects still abstinent, while the number was only 10% for the placebo patients.
These numbers might still seem impressing, but we are missing something very important here, and that’s the effective and ongoing counseling or support that the subjects were getting. Once we take these support programs out of the equation, the number will surely drop further down from 25%. And let’s not forget that the thing every nicotine addict hates the most is quitting programs and professional face-to-face counseling.
So, unless there’s the usually unwanted support along with the drug, we might not be able to figure out the exact number in terms of Chantix’s success rate, however, it’s definitely more effective than most other smoking cessation aids as all the studies conducted for other products also involve some sort of counseling/support. Still, Chantix is not a magic pill, and should not be looked to as such. The purpose of Chantix is to ease the withdrawal symptoms in order to break the physical addiction, but the behavioral addiction must also be addressed in order to maintain a long-term tobacco-free status.
How to Take Chantix (Chantix Dosage)
Since your doctor will prescribe Chantix, the dosage will be specified by him/her. All you have to do is make sure you take exactly as they specified. Don’t take higher or lower amounts, or for longer than your doctor has recommended.
Varenicline doesn’t contain nicotine, so you can take it while you’re actively smoking. In fact, we have found a particular strategy to be more successful when you want to quit smoking with Chantix. To make it easy for you, here are the exact steps you should take:
- Set a quit date, at least one week and at most two weeks from the day you want to start taking the Chantix (Varenicline) pills.
- Your doctor will specify the dose you should take. You will need to start with small doses, and gradually increase over the next few days.
- Take the pill with a glass of water, about half an hour after eating your meal.
- STOP taking nicotine on your quit day.
- Keep taking your pills regularly.
- In case you’re about to run out of medicine, get a refill to ensure you don’t skip a single day.
- Keep in touch with your doctor, especially if you experience any severe side effects
How much Chantix costs will depend on several factors, like where you live, the pharmacy you get your medicine from, your insurance and so on. However, there is one thing for certain about Chantix that it’s expensive as compared to any other nicotine cessation aid because it’s protected by patents and no cost-effect generic version of Varenicline is available on the market.
Most insurance companies cover Chantix, so if you have insurance, you’ll be shelling out a small copayment. Otherwise, it can cost you $300, or even more, for a 30-day supply. The only thing you can do to get the best bang for your buck is shop around.
Nausea seems to be the most prevalent side effect of Chantix, followed by sleep disturbance, constipation, gas, and vomiting. Any patient beginning a new prescription should make the prescribing doctor aware of any known health conditions, but patients with heart or blood vessel disease are particularly vulnerable. Meanwhile, FDA updated labeling ruling for quit smoking drugs due to alcohol tolerance issues, so awareness of Warnings and Precautions is highly recommended. Any other stop smoking aids should also be discussed with a doctor prior to starting Chantix.
IMPORTANT ADVERSE HEALTH RISKS:
It has been reported that patients taking Chantix have developed serious mental health changes. These changes occurred in early use, after several weeks of taking it, and even after use was terminated. Some of the following changes were noted, but check with Chantix, your doctor, or a pharmacist for the full listing.
- Behavioral Changes
- Suicidal Thoughts and Actions
Patients with a history of any type of mental health problem like depression should offer full disclosure to their doctor regarding it. In addition, the patient, caretaker, and friends and family should be on the lookout for the onset or aggravation of any of the above-listed symptoms, or of any other mental health or behavioral changes.
Why Side Effects Occur?
There may or may not be an apparent reason for the side effects of Chantix to appear. The biggest reason of side effects from Chantix is usually an existing physical condition the user has. The ingredients of the drug can worsen the condition or result in other physical issues. FDA recommends taking one tablet of 0.5 mg for the first three days, followed by two 0.5 mg tablets for the next 4 days, and then 1 mg tablet twice a day for the rest of the period your treatment continues (which is usually 12 weeks). The other major cause of Chantix side effects is taking a higher dose or taking it for longer than the recommended length of time.
When taking Chantix, it’s recommended not to drink alcoholic drinks or at least minimize your consumption, because these two usually don’t get along fine. Likewise, if you are taking any other medication regularly, Varenicline can have a chemical reaction and cause adverse effects.
Are These Really Chantix Side Effects?
Whether you try to quit smoking with Chantix, any other nicotine replacement therapy (NRT), or without any aid, there are always certain side effects because of the withdrawal caused by a sudden cut in the regular supply of nicotine. Therefore, sometimes these side effects can be confused with side effects of Chantix. You may suffer depression, trouble sleeping, irritability, difficulty concentrating, and frustration when you stop taking nicotine, but the same effects are also attributed to Chantix. So, at times it can be difficult to tell the actual cause behind these side effects.
Common Side Effects of Chantix:
The most commonly observed side effects of Chantix include nausea, vomiting, gas, constipation, weakness, indigestion, sleep disturbance or even insomnia, dry mouth, weakness, headaches, stomach pain, feeling sad or empty, restlessness, loss of interest or pleasure in things you normally enjoy, depression, aggression, frustration, irregular heartbeat, and unusual dreams.
Side effects included on the package insert/label/medication guide are:
- Neuropsychiatric and Suicidal Symptoms
- Angioedema and Hypersensitivity Reactions
- Cardio Vascular Events
- Nausea and Vomiting
- Accidental Injuries
Doctors do not prescribe Chantix and sometimes patients stop taking Chantix followin these side effects.
Over 2,300 complaints pending against Pfizer.
Some of these side effects may persist for up to several months, even when you stop taking Chantix.
Uncommon Side Effects of Chantix:
The rare side effects include seizures, behavioral changes, difficulty in breathing, hyperventilation, tightness in the chest, suicidal thoughts, fever, cough, chills, itching or skin rash, loss of appetite, sneezing, sore throat, stuffy nose, loss of voice, and hallucination.
Severe Side Effects of Chantix that Need Emergency Medical Help
Consider getting immediate medical help, if you experience any of these side effects: skin rash, difficulty breathing, swelling of your face, tongue or lips, hyperventilation, extremely high heartbeat, blood in urine or stool, sudden severe headache, fever, sudden numbness of some body parts, and tightness in the chest.
As soon as you feel any of these effects, stop taking the pills and call your doctor right away.
Side Effects from Chantix for Pregnant/Lactating Women
Currently, we don’t have any enough adequate data or studies on whether pregnant women are at a greater risk by using Chantix or not, or whether it has the potential to secrete in breast milk. As a matter of fact, most people quit smoking or taking nicotine when they are about to become parents, you doctor might still warrant you to use the drug despite the potential risks or they might suggest an alternate aid for cessation.
How to Minimize the Risk of Chantix Side Effects
If you plan on using Chantix, you should have an in-depth discussion about it with your doctor. As we mentioned earlier that people who have any kind of physical disorder are more prone to suffering Chantix adverse effects, so if you have any of these conditions, offer your doctor a full disclosure before you embark on your cessation journey: history of seizures, kidney problems, kidney dialysis, alcohol addiction, heart diseases, blood vessel disorders, pregnancy, breastfeeding, or any mental issue you have or had in the past.
Remember, Chantix shouldn’t be used if you are under the age of 18. Also, this list does not contain all the possible side effects of Chantix. Every human being is unique and can experience unique side effects depending on their age, physical health, physical issues, and addictions.
Zyban Vs Chantix
While Chantix is the marketing name of Varenicline, Bupropion is marketed under the brand name of Zyban, which is mainly an antidepressant but is also used as a nicotine cessation aid. Just like Chantix it has been approved by FDA and doesn’t contain nicotine, but stimulates hormones in the brain to help cope with nicotine cravings. Since it doesn’t contain nicotine, it can be used with other NRTs or while you’re actively smoking.
Zyban is comparatively affordable but has lower success rate i.e. almost 30% after three months and almost 15% after one year. Just as we mentioned that chances of nicotine abstinence increase when you take Chantix with non-medication aid, Zyban is more effective when your endeavor to quit nicotine is accompanied by some sort of support program.
One particular study was conducted to see how Chantix stacks up against Zyban and placebo (sugar pills). The subjects were given two pills every day for three months. In addition, they were also offered support in the form of reading materials and counseling. The result showed that Chantix was the most effective, with placebo being the least effective. Here are the results of the study:
- Chantix success rate: 44%
- Zyban success rate: 30%
- Placebo success rate: 17%
While Zyban and Chantix are two different drugs, they work pretty much the same way and also have nearly the same side effects. No matter which drug you want to use as nicotine cessation aid, make sure you consult with your doctor and offer them comprehensive disclosure of any medical conditions you have. But if we were to pick either Chantix or Zyban, we’ll definitely prefer Chantix because of its higher success rate.
Smokers deserve better than Chantix. Much better.
There’s a memorable scene in Terry Gilliam’s masterpiece Brazil (1985), in which an elderly mother regales her audience with the problems she’s encountered from plastic surgery: “My complication had a bit of a complication.” Every time she has a scene in the film, her features are increasingly distorted.
I was thinking of the line “my complication had a bit of a complication,” after coming across an ad for Chantix in a popular magazine. The ad features “Lisa,” who is photographed and quoted as saying, “I honestly loved smoking. And I honestly didn’t think I would ever quit.”
Just below her text, if it is hers, the following “important safety information” appears in boldface, literally right in the middle of the ad: “Some people have had changes in behavior, hostility, agitation, depressed mood, suicidal thoughts or actions while using CHANTIX to help them quit smoking.” “While using” being the operative admission, with quite a few legal consequences, presumably. “If you, your family, or caregiver notice agitation, hostility, depression, . . . or you develop suicidal thoughts or actions, anxiety, panic, aggression, anger, mania, abnormal sensations, hallucinations, paranoia or confusion, stop taking CHANTIX and call your doctor right away.”
The text is so frank about the risks of serious side effects from the pill that one wonders why anyone would prescribe—much less want to take—it in the first place. Even when they’re desperate to quit smoking, as I remember being. I haven’t even gotten to the part about peeling skin, blisters, sleep problems, vomiting, and feared effect on pregnant women. Smokers deserve a lot better.
Such ads urge us to revisit and rethink why direct-to-consumer pharmaceutical advertising is, among developed countries, legal only in the United States and New Zealand.
I’m all for people wanting to stop smoking. I happened to do it cold turkey and it worked for me (though I doubt it would for everyone). Nowadays, I would probably step down with a nicotine-based chewing gum. But a pill known to cause even one of those dreadful side effects? Forget about it, Pfizer. Not going to happen.
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Sure, medicine is supposed to make you feel better—but before you go popping prescription pills, you may want to look into their side effects.
Patients who are taking the new anti-clotting medication Pradaxa have a 33 percent higher risk of experiencing vascular complications such as a heart attack or acute coronary syndrome, says a recent study published in the Archives of Internal Medicine.
Yet even though there was an increased risk for experiencing a heart attack, the authors noted that the meta-analysis found that the overall rate of death was actually lower for those on Praxada—4.83 percent versus 5.02 percent in the control groups.
And that’s not the only pill with some scary side effects. Check out these popular medications—some of the side effects are bizarre, to say the least.
More from MensHealth.com: 5 Medications to Avoid
Ambien (zolpidem tartrate) is commonly prescribed to treat insomnia. But upon closer inspection, it appears this little pill does much more than help the sleep-deprived catch some Zs. According to early case studies published in the journal Sleep Medicine, patients who were on Ambien began developing odd habits such as “sleep eating”— some having no memory of their odd behavior upon waking. Yet as time passed (and the side effects continued to worsen), the FDA slapped this on Ambien’s Medication Guide: “After taking AMBIEN, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.”
And as for those activities referenced above that you “may not remember”—that list was also printed on Ambien’s Medication Guide: driving a car (“sleep driving”), making and eating food, talking on the phone, having sex, and walking around.
If you’re looking for something a little less extreme to help you catch some shuteye, try an alternative such as Sonata. The pill—typically used by individuals who wake during the night and need to fall back asleep—will only keep you under for about 4 hours.
Chantix (or Varenicline) is prescribed to help you quit smoking. But after getting a load of this medication’s crazy side effects, you may feel safer quitting cold turkey. In a recent study published in the journal PLoS One, researchers analyzed more than 3,000 reports of suicidal behaviors or depression in people taking Chantix, Zyban,or nicotine replacement drugs and found that 90 percent of the reports were linked with Chantix. Since learning of all the extreme side effects associated with Chantix, the FDA placed a “black box” warning label on the drug—which is the strongest warning the FDA can give out—informing doctors and patients about the risks of depression, hostility, and suicidal thoughts.
The FDA also required the following statement to be published on the Medication Guide: “Serious neuropsychiatric events have been reported in patients taking CHANTIX”—as well as a lengthy list of side effects, including: serious skin reactions, cardiovascular events, night terrors, insomnia, nervous system disorders, and eye disorders.
If you’re looking to wean yourself off Chantix, aim for a more noninvasive method such as nicotine-replacement therapy (think the patch, gum, etc). According to research from the Cochrane Database of Systematic Reviews, these nicotine-replacement therapies can increase your chance of quitting by 50 to 70 percent. (And if you’re interested in more information on ditching the drugs, read on for easy ways to get off the meds.)
Ropinirole—also known as Requip—is used to treat individuals with Parkinson’s disease as well as restless legs syndrome. Common side effects include constipation, dizziness, increased sweating, lightheadedness, loss of appetite, nausea, vomiting, and weakness. But that’s not the strange part. It’s this: The Medication Guide lists “Falling Asleep During Activities of Daily Living” as it’s first side effect under its “warning and precautions” section. To quote, “Patients treated with ropinirole have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents.”
But if falling asleep sporadically throughout your day doesn’t catch your attention—the research published in the Mayo Clinic Proceedings just might. Researchers monitored the medical records of 267 patients who were taking Ropinirole between July 1, 2004, and June 30, 2006, and found that, due to the drug, nearly 20 percent of the subjects were documented with hypersexuality as well as experiencing the new-onset of compulsive gambling.
And although there is no cure for Parkinson’s, there are other treatment methods out there. If you’re looking to avoid meds, you could always try a more natural route. According to the National Parkinson Foundation, exercising (walking, jogging, or biking) can help ease the symptoms associated with Parkinson’s and improve a person’s coordination, motor function, and manual dexterity.
More from MensHealth.com: Goodbye Medication, Hello Meditation
Madeline Haller I’m the social media editor for Cosmopolitan.com, as well as a self-proclaimed expert on Internet cats (tough job, but hey, someone has to do it).
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