FDA Announces Safety Review of Yaz and Yasmin After Studies Show Blood Clot Risk

By June 2, 2011Dangerous Drugs

I’ve written here several times, from my perspective as a dangerous drug attorney, about the unreasonable risks posed by birth control pills containing drospirenone. The pills, whose most famous commercial names are Yaz and Yasmin, have been criticized for an alleged increased risk of life-threatening blood clots compared to older birth control methods. Now, the FDA announced May 31 that it will conduct a new safety review of birth control pills containing drospirenone, in response to two recently published studies showing a dramatic increase in that risk. Those studies, published in the online British Medical Journal, have also led European regulators to update the prescribing information for Yaz, Yasmin and their generics, and Health Canada announced that it too is reviewing the pills’ safety.
Venous thromboembolism is the scientific name for blood clots deep in the legs, which can be life-threatening if they break away and move through the body to the lungs, where they can cause sudden death through lack of blood flow, or shortness of breath, rapid heart rate and other serious symptoms. All birth control pills carry at least some risk of veinous thromboembolism, but the two studies, published in late April, found that women 15-44 were two to three times more likely to develop venous thromboembolism on drosperinone than they were with pills containing levonorgestrel, an older synthetic hormone. That was true even after the scientists controlled the data for other risk factors for blood clots.
These are not the first studies connecting drospirenone with blood clots, but they are the newest and most serious evidence. Previously, two 2009 studies made that connection, but two other studies found no increased risk compared to levonorgestrel or other synthetic hormones. The FDA added this information to its prescribing information requirements, but the new studies may spur it to add more serious warnings. The older studies also led to thousands of lawsuits against Bayer, the maker of Yaz and Yasmine, for failure to warn patients about the risks, misleading marketing and more.
As a defective prescription drug lawyer, I hope the FDA takes this new information as seriously as it warrants. Blood clots can kill, and at least some evidence suggests that they can kill people without obvious risk factors who are taking drospirenone. As I wrote last month, a New Jersey woman is suing Bayer over the death of her daughter, a college freshman who died suddenly of a fatal blood clot at the age of 18 — half the age of women considered at higher risk. The young woman had been described Yaz for acne control. Bayer maintains that the risk of blood clots is no higher with its drug than with other birth control, but the scientific evidence increasingly says otherwise. I hope the FDA places patient safety first when it decides how strong the warnings on the drugs’ labels should be.


Carey, Danis & Lowe represents clients around the United States who were seriously injured or lost a loved one because of a medication that was supposed to help them. Many Americans believe prescription and over-the-counter drugs wouldn’t be sold if they weren’t safe — but as patients and their families have found out the hard way, that isn’t true. As pharmaceutical liability attorneys, we work every day with families that have suffered a serious injury from an FDA-approved drug that they used as directed, but contained a serious safety flaw. We help those families collect financial damages to compensate them for the life-changing results: a death in the family or a permanent disability, lost income if the victim can no longer work, high medical bills and more.
If your family has suffered an injury or illness from a dangerous drug and you’d like to learn more about your legal options, you’re invited to contact Carey, Danis & Lowe for a free consultation. You can send us an email or call toll-free at 1-877-678-3400 today.