The government is now saying that Yaz is more likely to cause blood clots than other birth control pills. Of course, our government has not said that yet.
Health Canada this week posted an advisory after taking a long look at safety data on Yaz and Yasmin, a popular oral contraceptive. Their conclusion is what Yaz plaintiffs’ lawyers – and their clients who are filing lawsuits in massive number – have been saying: Yaz and Yasmin have 1.5 to 3 times higher risk of causing blood clots than other oral contraceptives. Health Canada stated that the risk of clotting is estimated to be 1.5 to 3 in every 10,000 women annually. Put that on the box.
Yaz and Yasmin contain drospirenone, which has been previously reported to cause blood clots. In a study published earlier this year in the British Medical Journal (BMJ) is one of five recent studies that has found drospirenone to have a higher risk of blood clot formation compared to other birth control pills. Any increase in risk is significant as blood clots can trigger more severe events including heart attacks, stroke or death.
Bayer has updated labels to include information to advise health care professionals to consider the risks and benefits of a specific patient in light of the possibility of developing blood clots while on drospirenone, relative to the risk and benefits of other oral contraceptives.
A panel of experts assembled by the FDA met yesterday to discuss the safety of drospirenone and voted 21 to 5 that the current labeling of Yaz and Yasmin was insufficient and should include more information about the risk of blood clots of the lungs and legs. The panel voted 15 to 11 that the benefits oral contraceptives containing drospirenone outweigh the risks. Though the FDA is not required to follow the expert panels recommendations, they often do.
The birth control pill was introduced in 2006 and by 2008 was the best selling oral contraceptive. In the past two years prescriptions have dropped 80% due to concerns regarding its safety. Drospirenone containing birth control pills accounted for approximately 16% of hormonal oral contraceptives prescribed last year in the United States.
The FDA expert panel found that the magnitude of the risk could not be properly assessed as many of the studies reviewed did not clearly identify other risk factors that may have been present and as such recommended that specific risk factors be studied in future trials.
On December 9, the FDA will vote on the risk/benefit ratio of a birth control patch, Ortho Evra, manufactured by Johnson & Johnson, which has also been linked to an increased risk of blood clots.
Women at risk of developing blood clots are advised to discuss their risk factors with their physicians. Risk factors include smoking, obesity and family history of blood clots. Women over the age of 35 who smoke more than 15 cigarettes per day are advised not to take any birth control pills as they are considered high risk of developing blood clots.
These Yaz lawsuits start going to trial next month. Hopefully, settlements and a drastic change in the warning label is on the way.