Yaz Side Effects: FDA Requires Increase Warning For Yaz Blood Clot Risks

A Food and Drug Administration (FDA) advisory panel voted 21-5 to require drospirenone-containing birth control pills – including Yaz, Yasmin, Ocella, Beyaz, Safyral, and Vestura – to warn about increased risk of blood clots.

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Bayer Pharmaceuticals, which makes Yaz, Yasmin, and Beyaz, has heavily marketed these contraceptives to young women as not only preventing pregnancy, but also preventing PMS and even controlling acne breakouts. However, the FDA has said Bayer went to far in its marketing claims about Yaz. The FDA sent Bayer a number of scolding letters and required Bayer to issue new advertisements retracting previous claims about Yaz's effectiveness.

You can read the FDA warning letters here:

• 2003 FDA Yaz Warning Letter
• 2008 FDA Yaz Warning Letter
• 2009 FDA Yaz Warning Letter

The link to blood clots in these contraceptives lies with the synthetic hormone, drospirenone. Drospirenone has been linked to serious side effects including blood clots, heart attack, stroke, pulmonary embolism, deep vein thrombosis (DVT), and even gallbladder disease.

In a recently released FDA funded study that compared several different types of oral contraceptives, those that contain drospirenone were shown to increase blood clot risks by 75%.

Here's an illustration showing how Yaz and other drospirenone-containing birth control pills cause blood clots and related serious side effects:

Blood clotting is a normal bodily function. This function normally stops blood flow from cuts and creates scabs to stop bleeding. This function repairs damage to the skin and other body tissues. However, the chemical combinations in Vestura, Yaz, Yasmin and Ocella can cause abnormal blood clotting. This results in blood clotting when it is unnecessary and inside the blood vessel, vein or artery.

These abnormal blood clots can break away from the blood vessel on which they formed. When these clots break away they travel through the blood stream and can form a blockage or become lodged inside the heart itself. This blockage can starve the flow of blood and cause a heart attack.

If the blood clot lodges in the brain (rather than the heart), it can result in a stroke.

If the blood clot lodges in the pulmonary artery that supplies blood to the lungs, it can result in a pulmonary embolism (or PE).

Ongoing Yaz Litigation

Thousands of women have sued Bayer, which makes Yaz, due to the serious side effects listed above.

More than 10,000 lawsuits have been filed against Bayer claiming that women have been harmed by taking Yaz or Yasmin, including accusations of about 100 deaths linked to the contraceptives.

In documents released recently in those lawsuits, David Kessler, a former FDA commissioner working as an expert for the plaintiffs, said that Bayer researchers found increased reports of blood clots in women using Yasmin in the United States, compared with those using three other pills, but did not provide that information to the FDA in a 2004 safety review.

"Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin," Dr. Kessler testified. He also said the company promoted the pill for alleviating premenstrual syndrome, when it was not approved for that use.

Source: NY Times

Thousands of these cases have been consolidated for pre-trial work up in Multi-District Litigation (MDL) pending in the United States District Court for the Southern District of Illinois.

"MDL" is shorthand for "multi-district litigation". Many people may refer to an MDL as a "class action", but there are some important differences between an MDL and a class action.

In a class action, only a few people (the class representatives) sue on behalf of a large number of other people (the class). In multi-district litigation, each individual plaintiff maintains his or her own claim.

Although some states have MDL litigation, most MDLs occur in federal court. For MDLs like Yaz, the process begins when users of the drug begin experiencing dangerous side effects. As these users become injured from this dangerous drug, they begin filing lawsuits across the country. Because these lawsuits each involve similar claims (defective and dangerous drug) and similar injuries (dangerous side effects including heart attack and stroke), the federal court will consolidate all of the claims in front of one judge.

Once the MDL court has been established, all new cases involving the same drug (Yaz or Yasmin) will be transferred to the MDL court. The idea is to have a small number of experienced attorneys handle the pre-trial proceedings for all MDL claimants.

The first Yaz birth control lawsuits from the MDL are expected to go to trial in January 2012.

It is a positive first step that the FDA advisory panel wants an increased warning to unsuspecting patients about the health risks from these contraceptives. However, it is disappointing that the panel concluded (on a much closer 15-11 vote) that benefits of these drugs outweighed their risks. Tell that to a young woman who has suffered a heart attack, stroke, or PE from these drugs.

[More on Yaz Side Effects and Litigation]

Read More:

• Stronger warnings urged on safety of new birth control pills [Rob Stein at The Washington Post]
• More Detail on Risk Urged for a Contraceptive Label [Pam Belluck at The New York Times]
• FDA Panel says Yaz and related contraceptives must carry more information on blood clot risk [AP via Washington Post and Bloomberg]
• FDA Hearing On The Increased Risks of Yaz/Yasmin [Katie Gommel at Fighting for Justice]

(c) Copyright 2011 Brett A. Emison

Follow @BrettEmison on Twitter.