FDA Favors More Risk Info on Birth Control Pills (Yaz)

(December 8, 2011) The Food and Drug Administration (FDA) will ask outside experts on Thursday about Yaz and several other birth control pills that contain a man-made hormone called drospirenone, which was heavily marketed as carrying fewer side effects than the earlier drugs.  But over the last two years, several large, independent studies suggest the rate of blood clots with drugs with the hormone is slightly higher than with other drugs. Most recent analysis by the FDA looked at medical records of 800,000 US women and found that the risk of a blood clot with drospirenone-containing pills was higher than other hormone-based contraceptives. The overall rate of incidents was very low,  however, with an estimated 10 in 10,000 women on the new drugs experiencing a blood clot, compared with 6 in 10,000 women on older contraceptives per year.

 

Studies by German drugmaker Bayer, which markets Yaz and related pill Yasmin, found no increased risk of blood clots.  Of note is that clots can be caused by factors such as smoking, obesity and family history.

 

Comparing about six studies available, FDA scientists said the risk of blood clots appears most likely in the first 3-6 months of taking a drug and increases among older women. Most birth control drugs use a combination of two female hormones; estrogen and progestin, to stop ovulation and help block sperm. For decades, many women complain of bloating and mood swings as side effects. Yasmin was introduced in 2001 as the first birth control pill to use a new form of progestin called drospirenone, which seemed to have less side effects.

 

In 2006, a reformulated version of the drug, Yaz, was approved, claiming on the label that it decreased acne and severe types of mood disorders. Their slogan was “beyond birth control”, Bayer’s ads pitched Yaz to women in their 20’s as an alternative to older contraceptives. One ad featured young women singing Twisted Sister “We’re Not Gonna Take It” while popping balloons labeled “moodiness” and “bloating” and “acne”.  Within two years, Yaz has grown into the best selling birth control pill in the US with peak sales of $781 million in 2009, according to IMS Health.  Sales tanked more than 50% the following year after the company was forced to run corrective TV and magazine ads.  The FDA said the company’s commercials suggested Yaz could treat premenstrual syndrome. In fact, the drug has only been shown to decrease incidence of a much more serious mood disorder called premenstrual dysphoric disorder. In the first half of this year, Yaz ranked 4th among contraceptive pills sold in the US, behind Warner Chilcott’s Loestren, Johnson & Johnson’s Ortho Tri-Cyclen and a generic version of Yaz marketed by Teva Pharmaceuticals.

 

Newer drugs like Yaz are no more effective than older pills, generally allowing one unplanned pregnancy per year for every 100 women.  In fact, the newer birth control pills may even be riskier and pose more of a threat in older women, especially smokers and women who are overweight. It seems that newer may not always be better. Then again, maybe having a child is better than dying of a blood clot. If you have developed any symptoms or side effects as a result of taking Yaz or Yasmin, you may be entitled to compensation. Please stop by our website or contact us at 1-800-246-4878 to speak with one of our attorneys.

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