December 6, 2011 — Two FDA committees will meet later this week to decide whether to require new safety measures on some popular oral birth control pills. Several recent studies have linked the pills to a higher risk of blood clots, which can cause serious side effects such as heart attack, stroke, and pulmonary embolisms.
Although all birth control pills that contain progestin (a female sex hormone) increase a woman’s risk of developing blood clots, the newest form of synthetic progestin (called drospirenone) appears to increase this risk substantially more than levonorgestrel, an older form of synthetic progestin.
In addition to the issues with drospirenone, the manufacturers of Yaz and Yasmin are under intense scrutiny because the FDA found that the advertising campaign misled consumers into believing that the products were safer than other contraceptives, they had fewer side effects, and they were approved to treat PMS and severe acne. In reality, Yaz and Yasmin have very serious side effects — women have died as a result of blood clots associated with their use — and they are only approved to treat mild acne and symptoms of Premenstrual Dysphoric Disorder (PMDD).
Last year, women in the U.S. spent more than $3.4 billion on contraceptives. In an aggressive attempt to seize a large share of this market, Bayer AG spent more than $270 million on the TV advertising campaign for Yaz and Yasmin between 2007 and 2010. This high-budget ad campaign is partially responsible for making Yaz and Yasmin the most popular birth control pill in 2008 and 2009.
However, the ads failed to warn consumers of the serious, life-threatening side effects — according to the FDA, this misled consumers. After the FDA sent several warning letters, Bayer was forced to run a corrective advertising campaign to include updated safety information. In 2010, sales of Yaz plummeted more than 50%. It still remains the fourth most popular birth control pill in the U.S.
Several massive studies have found an increased risk of developing a blood clot while taking a drospirenone-containing birth control pill. The most recent is a study currently being conducted by the FDA, which is following nearly 800,000 women. Preliminary results found that the risk of developing a blot clot is 1.5-fold higher than other contraceptives. The difference is small: roughly 10 per 10,000 women experience a blood clot versus 6 per 10,000 women on levonogestrel-containing contraceptives. Still, if older forms of birth control are just as effective at preventing pregnancy and have a slightly lower risk of side effects, many women would choose the less risky contraceptives. The FDA committees will be considering this as they meet to discuss the subject.
Bayer is facing roughly 4,000 lawsuits from consumers who believe the pharmaceutical company should have gone to greater lengths to study the side effects of drospirenone, and also include safety information in its advertising campaign.