Today I spoke at the FDA Advisory Committee meeting on YAZ, Yasmin, Beyaz, and Safyral, which are all birth control pills made by Bayer. Bayer’s research indicates these pills are as safe as other birth control pills, but all the other studies show an increased risk of potentially fatal blood clots. One of the studies, funded by FDA, includes 800,000 women, and the results are very disturbing because it shows a higher risk of blood clots resulting from these types of contraceptive pills, and especially high risks for new users. In today’s testimony, we heard from patients and family members about women who have died or become disabled because of these blood clots. The medical costs are enormous and the human costs are incalculable. Just as disturbing, we heard that most of the doctors involved failed to recognize the symptoms as these women complained of excruciating leg pains and other symptoms of blood clots, as well as excessive levels of potassium – all symptoms that are included as warnings on the medication labels. The companies are selling dangerous birth control pills and the doctors are prescribing them and then many are clueless when their patients describe their symptoms and ask what’s wrong. That’s why the contraceptives containing drospirenone need to be removed from the market immediately.
Most of the Advisory Committee members stated that the benefits of these birth control pills do NOT outweigh the risks if compared to other birth control pills that are on the market. But Bayer, the manufacturer, was relieved because the Advisory Committee said that the benefits did outweigh the risks compared to unplanned pregnancy (which itself has risks). But that isn’t much to be proud of, is it?
Diana Zuckerman, Ph.D
President, National Research Center for Women and Families