Xulane patch side effects reviews

Ortho Evra is a transdermal hormonal patch that provides reliable contraception. Like most other hormonal contraceptives, the patch uses a combination of estrogen and progesterone. The patch does deliver a much higher dose of estrogen than most pills available today. As a result, it has a somewhat higher risk of weight gain than other alternatives, according to the Women’s Health Resource website.

Function

Ortho Evra is more than 99 percent effective at preventing pregnancy. The hormones in Ortho Evra work by preventing ovulation, thinning the uterine lining and thickening the cervical fluid, according to the Ortho Evra website. The hormones in Ortho Evra affect your entire body and may cause a variety of other side effects, including weight gain.

Significance

While the actual dose of estrogen in Ortho Evra is quite low, you will be exposed to significantly more estrogen on Ortho Evra than you would on the pill. This difference is due to the transdermal delivery system. The Ortho Evra website estimates that you will get about 60 percent more estrogen than you would using a standard (rather than a low-dose) oral contraceptive. Higher amounts of estrogen place you at higher risk for both weight gain and a number of other, more serious, side effects.

Considerations

Ortho Evra is not recommended for women over 198 lbs (90kg), according to the Medscape website and may be less effective if you weigh more than 176 lbs. (80kg). If you gain weight on Ortho Evra, you may need to consider whether the efficacy of your birth control is compromised. Use a back-up method or opt for a different contraceptive altogether.

Effects

According to the Birth Control Patch Side Effects website, many women report a weight gain of 10-to-30 lbs. when using the Ortho Evra patch. Older birth control pills with higher levels of hormones typically caused both fluid retention and true weight gain. The level of estrogen in the patch may cause similar side effects. The full product information for Ortho Evra reports that 2.7 percent of users experience weight gain.

Prevention/Solution

If you feel that the patch is the right birth control choice for you, you can mitigate the potential effects of weight gain with a healthy diet and regular exercise regimen. If your weight does creep upward, switching from Ortho Evra to a low-estrogen birth control pill may be a better choice, according to Women’s Health Resource website.

Photo Credit

  • need to diet image by Kimberly Reinick from Fotolia.com

When it comes to birth control, there are a lot of myths out there. And those myths might leave you with a lot of questions.

Click on the myths below to get the facts.

Side Effects

Birth control will make me gain weight.

Everyone is different. Birth control can have different side effects on different women. The truth is researchers have found no direct link between using hormonal birth control and gaining weight. Young women probably know at least one friend who swears birth control made her gain weight. Many women start birth control during a time when their body is going through other changes, so it can be easy to blame those changes on birth control. If you’re still concerned about gaining weight on hormonal birth control, talk to your health care provider. One option might be non-hormonal birth control, such as the copper IUD.

I heard the implant causes you to gain a bunch of weight.

Long-acting or low maintenance methods such as the implant or hormonal IUDs contain progestins, which do not cause weight gain. Many women begin using birth control methods when they are growing and their body is changing and naturally gaining weight. Eating healthy and getting regular exercise can help keep your body healthy and happy.

The shot will make me gain a bunch of weight.

The Shot (Depo Provera) can cause increased appetite, which can lead to weight gain. Three out of 4 women gained on average 1.4 pounds in the first year while on Depo. Remember: eating healthy and getting regular exercise keeps your body healthy and happy.

Depo (the shot) will make my hair fall out.

Maybe. Depo-Provera (aka the shot)’s manufacturer reports 1 to 5 percent of women who receive injections experience hair loss or no hair growth. A Cornell University study found 10 percent of those surveyed experienced some hair loss while using Depo. A drug’s side effects can’t be predicted on an individual basis. Realistically, a woman is not going to go bald or have noticeably thinner hair on the shot. If you do experience Depo-related hair loss, your hair will grow back when you discontinue using this birth control method. If you’re concerned about this potential side effect, talk to your health care provider and see if there is another method that is right for you.

Birth control will imbalance my hormones and make me “crazy.”

The hormones found in birth control are similar to a woman’s natural hormones. Stress has been found to have a greater effect on your hormones than birth control. If you’re concerned about the ways birth control might affect your hormones, talk to your health care provider about low-dose hormonal birth control or even non-hormonal birth control options, including the copper IUD.

Birth control pills cause cancer.

There is no evidence linking birth control pills to cancer. Some birth control options, including the patch, ring and IUD, are actually shown to reduce the risk of ovarian and uterine cancer.

Birth control will affect my ability to have children in the future.

Research shows long-term (and even short term) birth control methods do not affect your future fertility. That’s why women who use the pill regularly but accidentally forget to take it for a few days can get pregnant that month. Women who have an IUD and have it removed can then get pregnant. All birth control methods available at BC4Teens are completely reversible. They will not prevent your ability to have children in the future. Fertility varies from person to person. Birth control doesn’t affect your ability to have babies when you’re ready for them, but untreated sexually transmitted infections (STIs) can. That’s why doubling up (using condoms with your primary birth control method) is so important to prevent STIs and pregnancy.

IUDs can cause Pelvic Inflammatory Disease.

IUDs do not cause Pelvic Inflammatory Disease (PID). PID is rare. It only occurs in 1 percent of women who have an IUD. What causes PID? STIs. If you have an undiagnosed STI when you get your IUD, there can be an increased risk of an STI developing into PID during the first 20 days. After 20 days, the risk is the same for those with an IUD and those without.

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Birth Control Methods

No one uses birth control methods other than the pill and condoms.

Although birth control pills paired with condoms serve as an effective protection method for many young women, low-maintenance contraception usage – intrauterine devices (IUDs) and the implant – is on the rise. According to the Centers for Disease Control and Prevention (CDC), the use of low-maintenance birth control, like IUDs and implants, has more than quadrupled from 2002 to 2011-2013. Why are the implant and IUDs becoming so popular? You don’t have to do anything to make them work perfectly every time, they last for years and they are completely reversible. There is no worrying about taking a pill every day or getting a shot every three months. These low maintenance methods last for years at a time and are more than 99% effective. BC4Teens offers IUDs and implants – and our experts will discuss what option might be best with you.

I hear the ring falls out.

Once inserted, the ring will stay in place until you take it out. It should not fall out during activity or while going to the bathroom.

The patch can fall off.

The patch is very sticky and once placed should stay put until you remove it. It should not fall off during bathing or activity.

I hear IUDs can tear through the lining of your uterus.

It’s possible, but it’s not likely and not very common. In fact, about 1 in every 1,000 IUDs causes perforation of the uterus. Most perforations occur at the time of the insertion and do not cause lasting harm.

I hear IUDs can get lost in your uterus.

It’s possible, but it’s not likely. Occasionally, an IUD can work its way down through the cervix (it’s called expulsion.) It’s annoying, but it’s usually not dangerous. IUD expulsion occurs in 2-10 percent of users. The type of IUD and age of the user, among other factors, affect expulsion rates. If you are concerned that your IUD has been expulsed or partially expulsed, use back-up protection like a condom and contact your health care provider.

You can only get IUDs if you’ve already had a kid.

IUDs are safe for women with and without children alike. In fact, the American Academy of Pediatrics recommends low maintenance birth control methods (like IUDs) as great birth control options for young women since they’re super effective, can last up to 10 years (depending on what kind you get) and are fully reversible.

The implant hurts.

The numbing solution you’ll receive before the implant is inserted will probably pinch more than the implant insertion itself. Your arm might be sore and bruised for a couple days. If the soreness persists after the first week of insertion, talk to your health care provider.

I want the implant but I’m afraid everyone will be able to see it.

As with all low maintenance birth control, no one has to know it’s there but you. You’ll be able to feel the implant if you press on your arm near the spot where it was inserted. If others are watching your arm while you’re pressing it, they might see it too. As long as you’re not drawing attention to it, no one will know it’s there.

I don’t have to take birth control because they make male shots/male pills now.

Condoms and vasectomies remain the only two birth control options for men today. Although researchers are studying a number of male birth control options, nothing is on the market just yet. So the next time you hear guys talking about being on the male birth control pill or the male birth control shot, know it’s not true.

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How Well It Works

I can’t remember to take something every day, so there’s not a birth control for me.

We get it. Your life is busy. And yes, with birth control pills, you have to take them every day for true effectiveness. But they aren’t your only birth control option. If you’re struggling to remember your pills, there are lots of other birth control options out there: such as the shot, the patch, the ring and low-maintenance birth control methods: IUDs/the implant. Low maintenance birth control methods are just that: low maintenance! You don’t even have to think about them! Once they are in place, they’re guaranteed to work: no matter how busy your hectic schedule becomes. And they are completely reversible. So once they are removed by a health care provider, they no longer work: and you could get pregnant.

The pill protects me from sexually transmitted infections.

The pill does not protect you from sexually transmitted infections (STIs.) The only birth control methods available that protect against STIs are the male and/or female condom; however, they are not the most effective method at protecting against pregnancy. So it’s important to use dual protection (condoms + another form of birth control) to prevent STIs and pregnancy every time.

If I miss three pills in a row, I can just take three in a day to prevent pregnancy.

Any time you forget to take a pill, you must use a back-up method, like the condom. Every time you forget to take a birth control pill, you increase the chance of pregnancy. If you constantly forget to take your pills, talk to your health care provider about low-maintenance birth control options, such as the implant or an IUD.

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Sex & Birth Control

There are no benefits to birth control if you’re not sexually active.

Many young women who are not sexually active choose to use birth control for a variety of reasons — some not even related to pregnancy prevention. Reasons may be related to heavy menstrual bleeding, cramping or acne. If you’re considering sexual activity or have been sexually active in the past, being on birth control is the smart decision. Talk to your parents and provider about what method is right for you.

I don’t need birth control because my partner pulls out.

Like all birth control methods, the pull out (or withdrawal) method is most effective when you use it correctly every time. Of every 100 women, 27 will become pregnant each year. That’s about a 27 percent failure rate. Plus, it’s important to remember that sperm can leak out during sex before ejaculation. So even if he pulls out, you can still get pregnant, and if you are not using a condom, you can get an STI. Only 100 percent complete abstinence can protect you against STIs and pregnancy 100 percent of the time. If you’re going to have sex, use dual protection (birth control + a condom.) It’s the only way to protect against STIs and pregnancy every time.

I’ve had unprotected sex and didn’t get pregnant, so I don’t need birth control.

Having sex without birth control doesn’t mean you can never get pregnant. It just means you got lucky. Do you really want to keep testing your luck? Whether it’s a woman’s first time or hundredth time having sex: any time a man and woman have unprotected sex, she can get pregnant.

I only have sex during or right after my period so I can’t get pregnant.

Any time you have unprotected sex, there’s a chance you’ll get pregnant. Most women ovulate approximately 14 days after the start of their last period, but many women have unpredictable ovulation. That means it’s possible to get pregnant any time during your cycle. Plus: Sperm can stay alive for several days after sex. Don’t take a chance. Use birth control + a condom every time, the whole time.

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Is there a way to lose weight on birth control?

Share on PinterestResearchers do not yet know if birth control pills cause weight gain.

Scientific studies draw mixed conclusions in the debate over whether birth control pills, otherwise known as oral contraceptives, cause weight gain.

According to the U.S. National Library of Medicine, the potential ways that women could gain weight include:

  • fluid retention
  • muscle gain, as muscle weighs more than fat
  • increase in body fat

These, however, are theoretical scenarios when someone is using hormonal contraceptives for birth control, and they remain unproven.

Despite the lack of scientific evidence, some women taking combined contraceptives believe that they increase their appetite and cause them to feel hungrier. Again, this is not easy to establish, as those who do not take contraceptive pills can gain weight as they age.

Why is it hard to prove birth control causes weight gain?

Scientists have difficulty creating large-scale studies to prove or disprove the theory that birth control pills cause weight gain.

To do this, researchers would have to take two groups of women and give some birth control pills with hormones, while giving placebos, or birth control pills without hormones, to others.

However, this would be difficult because people could not be sure they were in control of preventing pregnancies. Launching a very conclusive study is, therefore, difficult.

What do scientific reviews suggest?

The Cochrane Library, which conducts reviews of scientific research and evaluates available references, has published some information on birth control pills and weight gain.

The first systematic review evaluated the effects of progestin-only contraceptives on weight gain, concluding that the evidence of more than half the studies was “low-quality.”

In the studies, participants gained fewer than 4.4 pounds, on average, after 6 or 12 months of starting progestin-only birth control pills.

The second Cochrane Library review looked at the effects of combined hormone birth control pills on weight gain. These pills contain progestin and estrogen. The researchers found there was insufficient evidence to conclude that these birth control pills caused weight gain.

According to the U.S. National Library of Medicine, it is “unlikely” that birth control pills cause significant weight gain. The organization did, however, acknowledge that individual women might respond differently to medications taken.

Birth Control Patch

Birth Control Patch: Side Effects, Effectiveness, and Costs

The birth control patch is a thin plastic patch (1 3/4 inch square) placed directly on the skin of the woman. It is a hormonal method of contraception obtained by prescription.

How does the Patch Work?

The birth control patch works by hormones that are absorbed from the patch into your system.

The patch prevents pregnancy in one of three ways:

  • First, it prevents eggs from being released from the ovaries.
  • Second, it thickens the cervical mucus preventing the sperm from reaching the egg.
  • Third, it changes the lining of the uterus preventing implantation. Ethical Consideration.

How Do You Use the Birth Control Patch?

The patch is a prescription and must be obtained from your healthcare provider. The patch is worn for one week at a time and it is placed directly on the skin of your buttocks, stomach, upper arm or upper torso.

The patch is replaced once a week on the same day each week for three weeks in a row. The patch is not worn during the fourth week to allow your menstrual flow to occur at this time.

How Effective is the Birth Control Patch?

The patch has a failure rate of less than 1% when it is used correctly and consistently. The patch may not protect you from pregnancy if you are taking antibiotics or medications for fungal infections or seizures. The patch may not prevent pregnancy if you weigh 198 pounds or more.

What are the Side Effects or Health Risks of the Birth Control Patch?

The patch has side effects similar to those experienced by users of oral or other hormonal types of contraception including:

  • Skin irritation
  • Headaches
  • Breast tenderness
  • Irregular vaginal bleeding
  • Moderate weight gain
  • Nausea and vomiting
  • Bloating

Additional side effects may include yeast infections, contact lens problems, and depression.

The birth control patch should not be used by women who:

  • Smoke
  • Have high blood pressure
  • Have breast or uterine cancer
  • Have a history of blood clots
  • Have uncontrolled diabetes
  • Have a history of heart attack or stroke
  • Are allergic to hormones
  • Have diabetes
  • Have liver disease
  • Have unexplained vaginal bleeding.

Additional information was released from the FDA in late 2005 to warn patients and health care providers that the patch exposes a woman to more than 60% more estrogen than the birth control pill. This increased level of estrogen can lead to risks such as blood clots, strokes, and heart attacks.

Contact your healthcare provider immediately if you experience any of the following:

  • Chest pains
  • Redness, swelling, or pain in your legs
  • Abnormal or irregular vaginal bleeding
  • Jaundice (your skin looks yellow)
  • If you are experiencing pregnancy symptoms

Women who wish to use the birth control patch should seek additional consultation with their physician if they are experiencing any of the following medical concerns:

  • Depression
  • Diabetes
  • High blood pressure
  • High risk for heart disease
  • History of blood clotting conditions
  • History of liver disease

Is the Birth Control Patch Reversible?

Yes. Ovulation usually returns within three menstrual cycles after discontinuing the patch. Pregnancy is possible when you stop using the birth control patch.

How Much Does the Birth Control Patch Cost?

Office visits to obtain a prescription for birth control patches range from $50 to $200. A monthly supply of patches costs approximately $30-$35.

What About the Birth Control Patch and Sexually Transmitted Infections (STIs)?

The birth control patch should NOT be considered as a means for protection against the transmission of sexually transmitted infections.

Frequently Asked Questions About the Birth Control Patch:

The patch begins to work immediately, but the second form of birth control should be used during the first seven days of the first month the patch is used.

What day should I start using the patch?

Your “change patch day” is determined during the first month you start. It may either be the first day after your period ends or the Sunday following the start of your period.

Should I wear them in the same place?

When you change your patch each week, it should be worn in a different approved location. This keeps your skin from getting dry or irritated.

Can I use it while I am breastfeeding?

If you have recently been pregnant or if you are breastfeeding, it is best to consult your physician for the best time to start using the patch.

What do I do if the patch comes off?

If the patch comes off, it is best to replace it with another patch right away. If you do this within 24 hours, no backup method should be necessary.

Can I wear the patch in the water?

The patch may be worn during exercise, swimming or bathing.

What if I don’t like where I put it?

The patch should not be moved once it has been applied until the week has been completed.

Can I make it smaller?

The patch should not be trimmed or altered in any way, and additional adhesives including tape should not be used to keep the patch in place.

What are the Pros and Cons of the Birth Control Patch?

  • Highly effective when used correctly
  • You do not have to remember to take a pill each day
  • You do not have to go to the doctor’s office for a shot each month
  • Does not inhibit sexual spontaneity
  • Minimal side effects
  • It is reversible

The Cons include:

  • Does not protect against sexually transmitted diseases.
  • Requires a prescription
  • Requires weekly application
  • Increased exposure to estrogen, which can cause other health complications

More helpful articles:

  • Types of Birth Control
  • Birth Control Failure
  • Birth Control Pills

Xulane

SIDE EFFECTS

The following serious adverse reactions with the use of combination hormonal contraceptives, including Xulane, are discussed elsewhere in the labeling:

  • Serious cardiovascular events and stroke
  • Vascular events, including venous and arterial thromboembolic events
  • Liver disease

Adverse reactions commonly reported by users of combination hormonal contraceptives are:

  • Irregular uterine bleeding
  • Nausea
  • Breast tenderness
  • Headache

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to norelgestromin and ethinyl estradiol transdermal system in 3330 sexually active women (3322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (norelgestromin and ethinyl estradiol transdermal system or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%).

The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability.

Adverse drug reactions reported by ≥ 2.5% of norelgestromin and ethinyl estradiol transdermal systemtreated subjects in these trials are shown in Table 3.

Table 3: Adverse Drug Reactions Reported by ≥ 2.5% of Norelgestromin and Ethinyl Estradiol Trans dermal System-treated Subjects in Three Phase 3 Clinical Trials

System/Organ Class * Adverse reaction Norelgestromin and Ethinyl Estradiol Transdermal System
(n = 3322)
Reproductive system and breast disorders
Breast symptoms† 22.4%
Dysmenorrhea 7.8%
Vaginal bleeding and menstrual disorders† 6.4%
Gastrointestinal disorders
Nausea 16.6%
Abdominal pain† 8.1%
Vomiting 5.1%
Diarrhea 4.2%
Nervous system disorders
Headache 21.0%
Dizziness 3.3%
Migraine 2.7%
General disorders and administration site conditions
Application site disorder† 17.1%
Fatigue 2.6%
Psychiatric disorders
Mood, affect and anxiety disorders† 6.3%
Skin and subcutaneous tissue disorders
Acne 2.9%
Pruritus 2.5%
Infections and infestations
Vaginal yeast infection† 3.9%
Investigations
Weight increased 2.7%
*MedDRA version 10.0
†Represents a bundle of similar terms

Additional adverse drug reactions that occurred in < 2.5% of norelgestromin and ethinyl estradiol transdermal system-treated subjects in the above clinical trials datasets are:

  • Gastrointestinal disorders : Abdominal distension
  • General disorders and administration site conditions : Fluid retention1, malaise
  • Hepatobiliary disorders : Cholecystitis
  • Investigations : Blood pressure increased, lipid disorders1
  • Musculoskeletal and connective tissue disorders : Muscle spasms
  • Psychiatric disorders : Insomnia, libido decreased, libido increased
  • Reproductive system and breast disorders : Galactorrhea, genital discharge, premenstrual syndrome, uterine spasm, vaginal discharge, vulvovaginal dryness
  • Respiratory, thoracic and mediastinal disorders : Pulmonary embolism
  • Skin and subcutaneous tissue disorders : Chloasma, dermatitis contact, erythema, skin irritation

1Represents a bundle of similar terms

Postmarketing Experience

The following adverse reactions (Table 4) have been identified during postapproval use of norelgestromin and ethinyl estradiol transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 4: Alphabetical List of Adverse Drug Reactions Identified During Postmarketing Experience with Norelgestromin and Ethinyl Estradiol Trans dermal System by System Organ Class*

System Organ Class Adverse Drug Reactions
Cardiac disorders Myocardial infarction†
Endocrine disorders Hyperglycemia, insulin resistance
Eye disorders Contact lens intolerance or complication
Gastrointestinal disorders Colitis
General disorders and administration site conditions Application site reaction†, edema†
Hepatobiliary disorders Blood cholesterol abnormal, cholelithiasis, cholestasis, hepatic lesion, jaundice cholestatic, low density lipoprotein increased
Immune system disorders Allergic reaction†, urticaria
Investigations Blood glucose abnormal, blood glucose decreased
Metabolism and nutrition disorders Increased appetite
Neoplasms benign, malignant and unspecified (Incl. cysts and polyps) Breast cancer†, cervix carcinoma, hepatic adenoma, hepatic neoplasm
Nervous system disorders Dysgeusia, migraine with aura
Psychiatric disorders Anger, emotional disorder, frustration, irritability
Reproductive system and breast disorders Breast mass, cervical dysplasia, fibroadenoma of breast, menstrual disorder†, suppressed lactation, uterine leiomyoma
Skin and subcutaneous tissues disorders Alopecia, eczema, erythema multiforme, erythema nodosum, photosensitivity reaction, pruritus generalized, rash†, seborrheic dermatitis, skin reaction
Vascular disorders Arterial thrombosis†, cerebrovascular accident†, deep vein thrombosis†, hemorrhage intracranial†, hypertension, hypertensive crisis, pulmonary embolism†, thrombosis†
*MedDRA version 10.0
†Represents a bundle of similar terms

Read the entire FDA prescribing information for Xulane (Norelgestromin and Ethinylestradiol Transdermal System)

When choosing a method of birth control, most women want what is the most effective and convenient. Women who want “hormonal” birth control can choose a pill, patch, injection, or vaginal ring. Using hormones for birth control has various benefits and risks. Over the past several years scientists discovered that some forms of birth control have higher risks than others. The Patch was shown to put women at greater risks than birth control pills by exposing women to higher levels of estrogen. How does the Patch work, and why is it more dangerous than other forms of birth control?

Hormones and Birth Control

Hormonal birth control has either an estrogen/progestin combination, or just progestin alone. These are the two hormones naturally produced by a woman’s body that cause
her to have her period. When this type of birth control is used, an artificial stream of hormones is released into the body. This keeps your ovaries from releasing new eggs during a menstrual cycle—which in turn prevents pregnancy. Hormones from the Patch are absorbed through the skin. People who use the Patch apply one patch a week for three weeks and then have an “off week,” just like if they were on the Pill.

However, research scientists discovered that there are many ways that the Patch is not like the Pill. Birth control pills release about 35 micrograms of estrogen a day, which is considered a safe amount. In high doses estrogen can be dangerous and cause side effects such as blood clots, strokes, and heart attacks. Researchers have shown that the Patch exposes a woman to about 60% more estrogen than the Pill. This much higher amount of estrogen can increase the chances of these dangerous side effects.

FDA Updates for the Birth Control Patch

The first birth control patch, Ortho Evra, went on sale in the U.S. in 2002. In 2005, the Food and Drug Administration (FDA) required that Ortho Evra’s label include a warning about the increased levels of estrogen in women who are on the Patch compared to the Pill. The warning also stated that women on the Patch might be more likely to develop blood clots compared to women on the Pill. The research studies at the time had mixed results and were not conclusive.

The FDA strengthened the warning in 2008 after more research studies were published that concluded that women on the Patch are more likely to develop blood clots compared to women on the Pill. In 2011 the FDA upgraded that warning to a “black-box” warning—the strongest warning that the FDA makes — only when drugs have serious and potentially life-threatening side effects.

Ortho Evra was discontinued in the U.S. after the FDA approved Xulane, a generic hormonal birth control patch, in 2014. Xulane delivers the same high levels of estrogen as the Ortho Evra patch. Like the Ortho Evra patch, Xulane’s label has a boxed warning of potential side effects. These include increased risk of heart disease, heart attack and stroke. Ortho Evra is still available in Canada and Europe.

Agile, another pharmaceutical company, is testing a new hormonal patch called Twirla. This patch works like Ortho Evra and Xulane, but it releases about half the estrogen each day. This should decrease side effects and still prevent pregnancy. In 2017, Twirla submitted data to the FDA in an effort to convince the FDA that its patch is effective as well as safe.

The Patch and Depression

A recent study by scientists in Denmark found that women who used hormonal birth control were more likely to be prescribed antidepressants compared to women who were not on birth control. Women who were on the Patch were the most likely to take antidepressants compared to women on all of the different forms of birth control that were studied. Teenagers who were on the Patch were the most likely to be treated for depression. While this study does not prove that the Patch causes depression, that is a logical explanation.

Who Should Not Use a Birth Control Patch?

While the FDA still claims that the Patch is a safe choice for some women, other experts are not so sure. In 2008. Johnson &amp; Johnson paid almost $69 million to settle lawsuits
filed on behalf of women who suffered from blood clots, heart attack, stroke, or death after using the Patch.

For women who are not at a particular risk for blood clots or stroke, the FDA still defends the Patch as a safe birth control method. However, the FDA does not compare the relatively safety of different birth control products with each other, they compare each to pregnancy, which also increases the chances of a healthy woman developing a blood clot, heart attack, stroke, or death. The FDA recommends that all women, especially women who smoke or are at risk for blood clots, talk with their health care provider about which method of birth control is best for them. Perhaps the most important question is: why take a risk with the Patch when safer alternatives are available?

To read more about the dangers of birth control pills containing drospirenone, click here.

To find out more about the symptoms of blood clots, click here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

When I saw the Today Show’s exposé of Johnson & Johnson (JNJ)’s Ortho Evra birth control patch — it fills women with an uninterrupted flow of hormones that create lethal blood clots — my first reaction was, this is an old story. I’ve been banging on about the dangers of Ortho Evra since 2007. J&J stopped actively marketing the product years ago. Why are they rehashing it now? Here’s the real reason, per NBC:

Public Citizen’s Sydney Wolfe petitioned the FDA two years ago to pull the patch off the market, but the FDA has yet to make a decision. The FDA told NBC:
It’s a complicated issue that takes time to review. In the meantime, girls are still — literally — dropping dead from the patch, such as Adrianna Duffy, a college freshman who collapsed in September 2009.

The FDA is running out of excuses for not making a decision about Ortho Evra. The history is a long one, and it reflects badly on J&J:

  • The patch has killed more than 40 women.
  • J&J has settled thousands of Ortho Evra lawsuits.
  • When the brand was launched in 2002, J&J’s ads frequently carried no warnings.
  • A J&J physician on the brand had a history of faking test results.
  • When a patient at New York’s Mount Sinai adolescent health center died from an Ortho Evra blood clot, J&J sales reps triples their visits to the staff there, treating them to breakfast and lunch until their concerns went away.
  • An FDA staffer reviewing J&J’s application to market the drug warned that the blood clot risks were actually twice what J&J’s stats said they were.

Although J&J doesn’t promote the brand any more, it still sells the drug and doctors still prescribe it for women who say they are forgetful about pills. Here’s J&J’s statement. There are safer, equally effective products on the market. The revenue is generates for J&J is so small it is not mentioned in the company’s most recent 10-Q. J&J should not wait for the FDA: Ortho Evra should be removed from the market before it kills anyone else.

Related:

  • Death of a Contraceptive: Merck’s Nuvaring Faces 300 Lawsuits
  • Schering’s Nuvaring Accused in Death; J&J’s Ortho Evra Reveals a Worst-Case Scenario
  • J&J Settles Fatal Patch Cases, So Why Is This Thing Still on the Market?

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