Pharmaceutical company Bayer is currently accused of withholding research findings from the Federal Drug Administration (FDA). Bloomberg reports the company faces over 10,000 lawsuits alleging they withheld findings of increased blood clots in users of Yasmin birth control pills.
Potentially Dangerous Drug
The concerns return attention to speculation around the safety of the primary hormone used in Yasmin, drospirenone. Oral contraceptives originally used a combination of the hormones estrogen and progestin, but, many users complained of increased bloating and mood swings. These concerns lead to the development of drospirenone. Drospirenone is a hormone designed to avoid these side effects while adding the benefits of soothing bloating, acne and moodiness.
Both the new and original contraceptive formulas posed a risk of increased blood clots. However, Businessweek reports "recent studies comparing the medical histories of women taking the newer drugs to older ones suggest a slightly higher risk of blood clots in the legs and lungs."
The controversy Bayer currently faces is the allegation of intentionally misleading both the FDA and consumers by falsely reporting the level of risk. Bloomberg reports that Bayer withheld details from an internal study finding two cases of clots in patients on the pill.
Reporting these findings would "impact the agency's risk-benefit equation about the drug and whether it could be approved."
Severe Injuries on Record
According to Bloomberg, the FDA further warned that women taking oral contraceptives in the Yasmin family were "74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives."
Such injuries are on record. One 20 year old reportedly died on Christmas Eve 2008. Her death occurred two months after she began to take Yasmin, and was caused by a blood clot that traveled to her lung.
Yasmin isn't the only form of birth control under scrutiny; others include Ortho Evra, Yaz and other pills using drospirenone. If you suspect that you or a loved one suffered an injury connected to a medication containing drospirenone, it is important to discuss your legal rights and remedies with an attorney knowledgeable in products liability matters.