The Food and Drug Administration has just announced that it has begun an assessment of new information in its ongoing safety review of birth control pills such as Yaz and Yasmin that contain drospirenone. The agency specifically said the review “will further evaluate the risk of blood clots in women who use these products.”
In a press release announcing the action the agency said: “All birth control pills pose a risk of blood clots. Several epidemiological studies have reported that the risk of blood clots for women who use birth control pills containing drospirenone is higher than that for women who use birth control pills containing the progestin levonorgestrel. Other studies have not reported in increase in risk.” One of the studies cited showed that women who used these drugs were two to three times more likely to suffer dangerous blood clots.
This announcement is sure to generate even more controversy over the safety of the drugs and whether the side effects are so dangerous that significant numbers of women may be putting their health at risk by using the drugs. These concerns have been raised by numerous health professionals and in medical research studies. They are also cited by consumer advocacy groups and by plaintiff’s lawyers who are suing Bayer Health Care, the manufacturer of the drugs, over these Yasmin blood clots, strokes and other health problems their clients have suffered from using Yaz and Yasmin.
The FDA refers to conflicting data from these epidemiological studies. Critics of the drugs note that the research raising concerns about the safety of the drugs was conducted by independent researchers while the main study that did not find increased risk was financed by Bayer.