New generation birth control pills like Yaz and Yasmin must come with warnings about the birth control pills side effects. The warning must be on the packaging that cautions against risks like the development of potentially deadly blood clots. Two Food and Drug Administration advisory committees have decided that the current labels do not adequately warn consumers about the dangers of pills, and hence, they have recommended that the agency require stronger warnings.
The controversy over side effects from new generation birth-control pills likely Yaz and Yasmin have been around for several months now. These pills contain a synthetic version of the progestin hormone. This synthetic version, drospirenone is believed to have plenty of other benefits, besides birth-control. Yaz was introduced in 2006, and quickly became a blockbuster drug for manufacturer Bayer. Yaz and other similar drugs were heavily promoted as containing several benefits for women, including prevention of acne and prevention of premenstrual syndrome.
However, safety concerns about the drugs began to emerge. According to some studies, there were signs that these birth-control pills were linked to a higher risk of blood clots. Blood clots are associated with strokes, heart attacks, pulmonary embolism, deep vein thrombosis, and even fatal blockages of arteries in the lung. In 2009, Danish researchers found that women who took Yaz and Yasmin and other similar birth-control pills were about twice as likely to suffer blood clots compared to those women who used other contraceptive pills.
The Food and Drug Administration has conducted its own studies, by analyzing medical records of more than 800,000 women. Researchers found that women who took these new generation birth-control pills, had a risk of developing blood clots that was approximately 74% higher than for women who were not taking these birth-control pills. Bayer currently faces thousands of personal injury lawsuits by women who developed blood clots after taking these birth-control pills.
Consumer groups like Public Citizen and women’s groups have pushed for the Food And Drug Administration to remove these drugs from the market altogether. However, two Food and Drug Administration advisory committees have decided that the benefits of the drug far outweigh any risks from them. These committees however have also recommended that the current labels be modified in order to more adequately warn consumers of the dangers of birth-control pills.
The Food and Drug Administration is not under any obligation to follow the recommendations of its advisory committees. However, the agency typically does follow these recommendations. The committees’ recommendations are a disappointment to San Diego defective product lawyers, who would have preferred a complete recall of these pills.