This update is in follow-up to the FDA Drug Safety Communication Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone. posted on 9/26/11:

(en Español)

Safety Announcement

The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills. See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.

The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.

Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; for women who use birth control pills; for pregnant women; and for women in the postpartum period. For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.

Figure 1: Likelihood of Developing a Blood Clot

COC = combination oral contraceptives or birth control pills

These studies were discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011. The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins. Previously published studies had reported conflicting findings. The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives. The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Today’s communication is in keeping with FDA’s commitment to inform the public about the Agency’s ongoing safety review of drugs. FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

Table 1. Approved Oral Contraceptives Containing Drospirenone

Brand name

Generic name

Beyaz

Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg

Drospirenone and ethinyl estradiol

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Drospirenone and ethinyl estradiol

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Gianvi

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Loryna

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Ocella

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Safyral

Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg

Syeda

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Yasmin

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Yaz

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Zarah

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Related Information

  • Information about Drospirenone
  • Updated External Questions and Answers:Ongoing safety review of birth control pills containing drospirenone and a possible increased risk of blood clots
  • Beyaz Label
  • Safyral Label
  • Yasmin Label
  • Yaz Label
  • FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone
  • FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone
  • FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone
  • FDA Briefing Information for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee (PDF 1.86MB)
  • FDA Drug Safety Podcast for Healthcare Professionals: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
  • Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre el riesgo de coágulos de sangre en las mujeres que toman pastillas anticonceptivas que contienen drospirenona

Are Your Birth Control Pills Safe?

Last year during my annual exam, when I complained to my doctor about my terrible PMS, she was quick to pull out her pad and give me a prescription for the birth control pill Yaz. “You’re going to love this,” she said. “All of my patients that are on it think it’s the best. It’s even helped some of them lose weight!”

Less PMS and not having to worry about my weight? I was sold, even though I’d only intended to talk to her about lifestyle and/or diet modifications since my birth control needs were already taken care of. Before I stopped into the pharmacy however, I looked up the pill online (Paging Dr. Google!). The results were anything but the love-fest I’d been promised. In fact, the information I found scared me so badly that I never filled that prescription.

It quickly became evident that I wasn’t the only woman concerned when Yaz and it’s sister pill Yazmin, two of the most popular pills on the market, came up for review by the FDA after reports that the manufacturer may have hid and minimized critical health risks. But is the hysteria warranted?

A November 2011 study found that the pills containing drospirenone, including Yaz and Yazmin, have a 43-percent to 65-percent higher risk of blood clots than earlier types of birth control pills. This, combined with widespread reports of side effects on the Internet, forced the FDA to take another look. In December 2011 an outside panel commissioned by the FDA ruled the drugs slightly more likely to cause blood clots but still safe for general use.

“It’s important to remember that all oral contraceptives are associated with a risk of blood clots,” Dr. Susan Solymoss of McGill University in Montreal adds in an editorial published with the study. And compared with the pills, “pregnancy is a bigger risk for blood clots.”

Still, the debate continues as a watchdog group is calling for the FDA to reconsider after it was found that four of the 26 panel members had ties to the manufacturer of Yaz and Yazmin. What should you do if you are currently taking these pills? Doctors say that the risk of clotting is greater in the first few months, so if you’ve been on them for a while and don’t have other risk factors-like smoking-then you’re probably all right. Still, you should always talk to our doctor about any concerns you have about your birth control.

  • By Charlotte Andersen

NOTICE: The Drug Law Center is no longer accepting these type of cases. This page is strictly for informational purposes. We appreciate your cooperation and understanding by not contacting our office on these cases. We are actively investigating and prosecuting cases involving Valsartan cancers. For information on Valsartan lawsuits, look here.

The Yaz injury case attorneys at the Drug Law Center are currently reviewing and investigating evidence from clients who have suffered serious injuries or died prematurely after using the popular birth control pill.

Introduction

Yaz (estrogen/progestin) is a popular birth control pill that contains both ethynyl estradiol and drospirenone to prevent pregnancy. Some doctors prescribe Yaz as a treatment for moderate cases of acne in females who are 14 years and older after they have begun their menstrual cycles and want an effective contraception medication. However, since it was first made available the medical marketplace, there has been significant controversy on whether the contraception pill is safe because it is more than likely to trigger the development of life-threatening blood clots when compared to other birth control pills. Some patients taking Yaz have experienced a stroke, serious breathing problems, and death.

The History of Yaz

The FDA first approved Yaz, the popular oral birth control pill, in March 2006 for the treatment of preventing pregnancy. By October 2006, the FDA extended the approval of Yaz for the treatment of premenstrual dysphoric disorder and in January 2007 for the treatment of moderate forms of acne.

When the drug was first launched in 2006, its popularity rose steadily amongst its competition until it was seated as the number one contraceptive pill in the United States. In recent years, Bayer Healthcare Pharmaceuticals has generated over $800 million annually in Yaz sales. This number dropped slightly in the last few years after thousands of women began filing Yaz injury lawsuits claiming that Bayer’s drug caused them serious harm.

Misleading Advertisements

Most consumers of medical products receive information through some form of media advertisement. In 2010, Bayer began and aggressive television advertising campaign that asked young women what they thought of the contraceptive pill. Many of the advertisers responded that taking Yaz would prevent common symptoms associated with birth control pills and the effects of premenstrual syndrome. However, the Food and Drug Administration never approved the medication for that condition, but instead, the drug was approved for premenstrual dysphoric disorder (PMDD).

Research studies indicated that many young women believed the medication also treated mild acne, which it does not. As a result, the FDA declared that the television advertisements had been misleading women in providing information that was not accurate or true. Even though many believed that the ads were deceptive, Yaz rose to the number one position as the most use birth control pill and the United States.

Who Should Not Take Yaz?

The individual suffering with hepatic dysfunction should avoid taking Yaz or any birth control product that contains ethynyl estradiol and drospirenone. Women should discuss all their health issues, conditions, and problems with their doctor before taking Yaz, especially if they have any of the following including:

  • Adrenal insufficiency
  • Renal impairment
  • High-risk potential of developing venous or arterial thrombotic disease
  • Smokers
  • Cardiovascular disease
  • Pulmonary embolism or deep main thrombosis
  • Coronary artery disease
  • Uncontrolled hypertension
  • Diabetes mellitus with vascular disease
  • Acquired or inherited hyper coagulopathies
  • Thrombogenic rhythm disease or thrombogenic valvular disease
  • Headaches with focal neurological symptoms or women 35 years or older suffering from migraine headaches
  • Breast cancer survivors
  • Those sensitive to progestin or estrogen
  • Depression
  • Protein C deficiency disease

Yaz Side Effects

All prescription medications and over-the-counter drugs have some form of side effects and adverse reactions that could be life-threatening or mild. The most common Yaz side effects include:

  • Headaches
  • Bloating
  • Vomiting or nausea
  • Stomach cramps
  • Irregular/missed periods
  • Spotting (vaginal bleeding) between menstrual cycles
  • Unusual changes during periods
  • Irritability
  • Bile flow issues causing yellowing eyes or skin
  • Head pain
  • Swelling of the abdomen
  • Full breasts caused by milk production
  • Fatigue
  • Tenderness, swelling, pain in the breast
  • Mood changes
  • Scalp hair loss
  • Increasing care growth
  • Vaginal discharge or itching
  • Fluid retention in the feet and ankles
  • Contact lens problems

Severe Yaz side effects include:

  • Benign liver cell tumors
  • Blood clots in the lung and veins
  • Cervical dysplasia (abnormal cervix lining cell growth)
  • Heart attack
  • Hepatitis
  • Liver cancer
  • Inflammatory ball disease
  • High bloodstream potassium levels
  • High bloodstream fat levels
  • Blood clot-related blood vessel obstruction
  • Water retention
  • Systemic lupus erythematosus
  • Gallbladder disease
  • Stroke
  • Brown/yellow patches on the skin

Yaz and the FDA

  • April 2012 – The U.S. FDA (Food and Drug Administration) released a Safety Announcement after the results of the study became public concerning women taking birth control pills containing drospirenone (synthetic progesterone), including Yaz. The study was in regard to the potential risk of these women developing blood clots. The conclusion of the study revealed that these women did have a higher risk for developing blood clots compared to other birth control pills that contain progestin.The FDA was quick to add that the reviewed studies “did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risks of blood clots.”
  • April 2012 – The Food and Drug Administration released an update on prescribing information contained in the Black box warning for Yaz. These warnings involved “Cigarette Smoking and Serious Cardiovascular Events”. The highlights included:
    • “Women over 35 years old who smoke should not use Yaz.
    • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.”
    • Contraindications to Yaz include “renal impairment, and renal insufficiency, a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen or progesterone-sensitive cancer, liver tumors or liver disease, pregnancy.”
  • May 2011 – The FDA has issued a Safety Announcement to consumers about birth control pills containing drospirenone. The announcement provided additional information on the female sex hormones drospirenone that prevents ovulation where eggs are released from the ovaries. The FDA was warning women that using these types of birth control medicines pose a risk of developing blood clots. Even so, the FDA stated that:
    • “If your birth control pill contains ethynyl estradiol and drospirenone, do not stop taking without first talking to your healthcare
    • Know the symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath…
    • If you smoke are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.”

Lawsuits

August 2015 – Bayer Healthcare Pharmaceuticals, the manufacturers of Yaz, agreed to pay out almost $57 million to settle numerous lawsuits filed by plaintiffs in state and federal jurisdictions alleging that the birth control pill caused heart attacks and strokes. This includes lawsuits that were filed in California, New Jersey, and Pennsylvania state courts.

The pharmaceutical giant agreed to make a payment to resolve the cases but did not admit to liability or wrongdoing. However, the settlement serves as a bellwether case to help other attorneys determine exactly how juries will respond when presented with similar evidence in individual cases nationwide.

October 2013 – A $1.4 billion payout by Bayer Healthcare Pharmaceuticals will settle nearly 6800 Yaz lawsuits. The settlement comes just a short while after the U.S. Food and Drug Administration cited Bayer about selling their product using false advertising, making women believe the product to deliver better health benefits without producing serious side effects common to other birth control drugs.

Yaz Lawsuits

Many women have stepped forward after suffering injuries when taking Yaz oral birth control pills and filed lawsuits against Bayer healthcare pharmaceuticals to obtain the financial compensation they deserved for their damages. Two of these lawsuits include:

  • Yaz Stroke Injury Lawsuit Filed by a Chicago Woman against Drug Maker BayerApril 2014 – $14 million has been awarded by an Illinois jury to resolve a Yaz stroke injury lawsuit where the plaintiffs suffered a life-threatening stroke after taking the birth control medication. The plaintiff received the award after proving that her doctor never should have prescribed the birth control drug because she suffered underlying risk factors for developing blood clots. It took just 13 days for the plaintiff to suffer a stroke after she was first prescribed the birth control pill in 2007.Her attorneys claim that the doctor was aware, or should have been aware, that his patient had an increased potential of suffering a stroke caused by blood clots that could have been avoided had she not taken the oral contraception pill.

    Even though this jury award is large, the drug manufacturer is facing many more days in court defending themselves against Yaz class action lawsuits because they insufficiently warned consumers of the potential dangers of developing blood clots. Some of these cases have already been consolidated in MDL (multidistrict litigation) cases filed in the Southern District of Illinois.

  • Yaz Blood Clot Injury Lawsuit Filed by Kentucky WomanMay 2014 – Bayer Pharmaceuticals is facing one more Yaz blood clot injury lawsuit, this time filed by a Kentucky woman who claims she sustained a life-threatening blood clot after taking the popular oral contraceptive pill. Lawsuit documents reveal that the plaintiff was prescribed Yaz by her doctor to prevent pregnancy and took the drug according to instructions by the pharmaceutical manufacturer. Shortly afterward, her doctors diagnosed with pulmonary embolism.The attorneys working on her behalf have filed a lawsuit claiming that Bayer Pharmaceuticals failed to provide warnings of the potential risk of taking the medication and had a duty to warn her, her doctor, and other consumers of the potential side effects. The plaintiff has claimed that had she understood how dangerous the medication was a producing serious side effects, she would have avoided taking the medication and found other alternative methods for preventing pregnancy.

Receive Monetary Compensation for My Yaz Lawsuit

The birth control drug injury attorneys at the Drug Law Center are currently investigating and evaluating potential Yaz lawsuits for class-action cases and individual claims. Many of our clients have taken oral birth control pills and suffered serious side effects including strokes, heart attacks, pulmonary embolism, deep main thrombosis, cardiac arrhythmia, gallbladder disease and sudden death.

If you or a loved one has been injured after taking Yaz for a short or long time, contact us today so we can begin the process of handling your financial compensation claim. We are currently accepting all birth control injury cases through contingency fee arrangements. This means we provide you immediate legal representation without the need for an upfront payment. Our law firm will postpone all payments for our legal services until after we have successfully resolved your case at a jury trial or through a negotiated settlement.

Schedule an appointment to speak with one of our attorneys now to discuss the merits of your case through a complementary, case evaluation. Any information you share with us will remain confidential.

Sources:

Birth Control Yaz – Still on the market and women still being injured

– August, 2013

In 2006 a new birth control pill entered the market. Yaz quickly became popular with its promise of not only offering pregnancy prevention, but that it could aid in weight loss and clear up acne. However, many women have been injured because of Yaz and other newer birth control pills.

The concerns over Yaz bombarded our news and televisions, but lately there has not been much talk about it. Please know, that women are still suffering from injuries sustained as a result of taking certain birth control pills.

To date, Yaz remains on the market yet many women have been injured. Yaz (in addition to Beyaz, Safyral, and Yasmin) contain, drospirenone. Drospirenone is a synthetic progesterone which increases the risk of blood clots and other health problems. The FDA (Food and Drug Administration) has found that there is a three fold increase in the risk for blood clots when women use products containing dropirenone.

Ladies, I know we take birth control for many different reasons. Some of us take it to prevent pregnancy, some to regulate our unpredictable periods, we do not however take it to develop blood clots or suffer other life threatening problems. If you take any of the above brands, ask your doctor about alternatives.

If you, or a woman in your life has been hurt as a result of taking Yaz, please call Feroleto Law. Any of our attorneys are happy to talk to you, but please know that if you are more comfortable discussing this with another woman, I am happy to speak to you. All conversations with any of our attorneys will be strictly confidential.

Yaz

Yaz is a prescription birth control pill. It was first approved by the U.S. Food and Drug Administration (FDA) in March 2006. Later in 2006, Yaz received FDA approval for use to treat premenstrual dysphoric disorder (PMDD). PMDD is considered to be a severe form of premenstrual syndrome (PMS). In 2007, Yaz received additional FDA-approval to treat acne vulgaris, which is the most common form of acne that primarily occurs from puberty through young adulthood.

Yaz is currently the best-selling birth control pill in the United States. While Yaz helped many women to prevent pregnancy and improve their menstrual cycles, it was also known to cause side effects such as migraines, kidney disorders, and uterine bleeding. There are currently thousands of lawsuits against Yaz manufacturer Bayer HealthCare Pharmaceuticals.

What Is Yaz?

Yaz and its sister drugs Yasmin and Ocella have a different chemical composition than most other birth control pills on the market. In addition to synthetic estrogen like other birth control, they contain drospirenone. Drospirenone is a new synthetic form of the hormone progesterone. It has a close chemical resemblance to spironolactone, which is a diuretic.

Yaz also provides patients with an increased hormone dose in comparison to other birth control pills. A month of Yaz treatment includes 24 active and four inactive pills. Most other monthly birth control regimens provide seven inactive pills.

Minor Yaz Side Effects

Like other birth control pills, Yaz users may experience minor side effects that do not pose significant health dangers. These side effects most commonly include changes in menstrual and non-menstrual bleeding.

Minor Yaz side effects can include:

  • Acne
  • Migraine heachades
  • Unusual vaginal discharge
  • Vaginal yeast infections
  • Stomach cramps
  • Changes in weight
  • Decreased sex drive
  • Problems with tolerating contact lenses

Severe Yaz Side Effects

Research has shown that those who take drospirenone birth control pills such as Yaz have an increased risk of developing dangerous blood clots. In fact, the risk is increased six to seven times compared to women who do not take any birth control. Compared to women who take levonorgestrel birth control, the risk of blood clots is doubled.

Yaz also interferes with the body’s natural potassium levels. For this reason, patients with renal or hepatic issues should not use Yaz. Women who begin a Yaz regimen should monitor potassium levels. Yaz can significantly increase potassium levels, which can lead to hyperkalemia. Patients taking other potassium-increasing drugs are advised not to take Yaz. Excessive potassium levels can cause serious injury or death.

Using Yaz may also cause:

  • Liver tumors
  • Disturbances in liver function
  • Stroke
  • Gallbladder complications
  • Hypertension, or high blood pressure
  • Deep vein thrombosis
  • Pulmonary embolism
  • Inflammatory bowel disease
  • Glucose level changes that can cause diabetes or affect lupus
  • Anaphylactic reactions, such as hives, itching, breathing difficulty, and swelling of the lips, face, or tongue

Yaz FDA Warnings

Since Yaz launched, it has received multiple FDA warnings and communications. Briefly after Yaz was released, Bayer received a fine for the marketing claims that the drug could cure conditions such as PMDD, acne caused by hormones, and other menstrual conditions.

In 2009, a warning letter was sent to Bayer due to a displeasing routine inspection of its German manufacturing plant. The FDA noted that some of the manufacturing equipment was unclean, and that the final products were not adequately tested before being shipped out to distributors.

There are currently more than 10,000 lawsuits against Bayer for the harmful side effects caused by Yaz. Yasmin and Ocella also face a number of lawsuits for similar side effects. In addition to the physical harm caused by Yaz, many lawsuits allege that Bayer implemented deceptive practices when marketing the drug. Plaintiffs feel that some claims for Yaz’s capabilities were exaggerated. Additionally, many feel that the health risks were not adequately communicated to consumers.

Yaz Recalls

Yaz is a fourth generation oral contraceptive made by German company Bayer. For those women using Yaz as a birth control, it can also be used to treat acne and symptoms of premenstrual dysphoric disorder. When Bayer first brought Yaz to market the company emphasized these bonuses, but downplayed the risks.

It is now known that Yaz increases the risk that a woman will develop a blood clot, which can be fatal. Although the U.S. Food and Drug Administration (FDA) has not issued a recall due to the dangers, nor has Bayer initiated one voluntarily, many women and advocate groups for consumers have been calling for a complete Yaz recall. They say the drug is too dangerous and should not be on the market at all.

Yaz – Fourth Generation Birth Control

Yaz is an oral contraceptive made by Bayer and belongs to the fourth generation of such medications. All oral contraceptives contain synthetic hormones that trigger various conditions that make becoming pregnant nearly impossible. In a dual-hormone contraceptive like Yaz there are two hormones: a synthetic version of estrogen and of progestin.

Yaz contains ethinyl estradiol as its synthetic estrogen. For a progestin, it uses drospirenone, and it is this compound that makes it a fourth generation oral contraceptive. It is the fourth reformulation of synthetic progestin. It is also drospirenone that causes serious potential health issues in some women and that has led a number of people to call for a Yaz recall.

Bayer first got Yaz approved by the FDA in 2001. The agency approved it to prevent pregnancy, but for women already taking it for this purpose, it is also indicated for treating moderate to severe acne and symptoms of premenstrual dysphoric disorder, like severe moodiness. Bayer came out swinging with Yaz in 2001 and promoted it heavily as a new birth control that could treat acne and mood swings. This combined with downplayed safety concerns would get Bayer in trouble.

The Risk of Blood Clots

Yaz quickly became one of the best-selling birth controls on the market, thanks largely to Bayer’s heavy marketing, which has been heavily criticized for playing up the benefits and minimizing risks. Before long, though, it was discovered that this birth control could also put women at serious risk of developing blood clots.

Blood clots most likely form in the legs. From there they pose no serious risks, but they can move through blood vessels, eventually causing blockages. A blockage in the heart, lungs, or brain can quickly become fatal. These clots can lead to heart attacks and strokes, and either immediate fatalities or serious and lifelong complications.

Although Yaz had been on the market since 2001, the FDA did not issue a warning about the risk of blood clots until 2011. The agency announced in May of that year that it was reviewing safety data and new sources of information about blood clots in women using Yaz. The announcement also stated that all oral contraceptives come with the risk of blood clots, but that new information suggested that risk could be higher with drospirenone.

FDA Action

Many individual women ended up suffering because of blood clots triggered by Yaz. It was on the market for ten years before women were notified of this risk, which means that there was a huge potential for harm. The risk has seemed high enough to some people to warrant a complete recall of the drug from the market. The FDA has so far disagreed.

After the initial warning in 2011, the FDA committed to further investigating Yaz and the blood clot risk and to determine if a recall was necessary. The preliminary results of an FDA study seemed to indicate that the risk of blood clots with Yaz was at least one and a half times greater than with other types of birth control. With the final results by 2012 the FDA concluded that the risk could be as high as three times. Instead of initiating a recall, though, the agency decided to only include additional label warnings and to recommend that doctors and patients weigh the risks and benefits before choosing to use Yaz.

The decision not to remove Yaz from the market came from an FDA advisory committee, which included independent experts. The group Project on Government Oversight, however, followed the meetings and the conclusion by the panel and was highly critical. The group pointed out that some of the members of the committee had ties to the drug industry and even financial ties to Bayer and could not be counted on to make an unbiased decision about recalling Yaz. The group called for the decision to be disregarded because none of these advisors had disclosed their conflicts of interest.

Limited Recall

Although there was no recall over the dangers of blood clot formation, the FDA did initiate a partial recall of Yaz in 2009 over other issues. The FDA, for reasons not clear, did not include the announcement of the recall in the “Recalls, Market Withdrawals, and Safety Alerts” part of its website. It placed the recall notice in a section on enforcement reports, and the recall went largely unnoticed.

The 2009 Yaz recall was over false reports by Bayer that some lots of the drug were within specifications, when in fact they were not. The specifications related to measurements of drospirenone in the pills, the compound now known to increase the risk of blood clots. Bayer averaged several numbers instead of using specific measurements and had to recall thousands of boxes of Yaz as a result.

Although consumers did not win in getting a recall of Yaz completely, many of those individuals affected by blood clots have received a portion of a $1 billion settlement. This is approximately how much Bayer has paid out so far in Yaz lawsuits, although it has consistently refused any wrongdoing or that the drug is any less safe than its competitors. As more evidence comes to light, it may be that Yaz will eventually be completely recalled. It is no longer as popular as it once was and women have other options when it comes to safe oral contraceptives.

Is yaz safe 2017

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