Controversy Continues Over Safety of Yaz Birth-Control Pills
The FDA is the federal government agency responsible for keeping us safe from pharmaceutical injuries by approving new prescription drugs for market, and regulating their manufacture and sale. Yaz, an oral contraceptive from Bayer HealthCare, was approved by the FDA in 2006.
While all birth-control pills heighten the chance of dangerous blood clots in users, pills with drospirenone have been shown in some more recent studies to have a higher risk than traditional oral-contraceptive formulas. Some older studies had different or inconclusive results so the regulatory road has been difficult and controversial.
Reuters reported that in late fall 2011, the FDA released its own findings that the risk of blood clots to women taking pills with drospirenone is about 10 in 10,000 in one year, up from six in 10,000 for other birth-control pill formularies.
Reuters stated further that a major new study of 330,000 Israeli women concluded in November 2011 that drospirenone-containing oral contraceptives create a 43 to 65 percent higher risk to women of developing unsafe blood clots than older pill formulas with different hormones do.
The types of blood clots at issue are:
• Deep vein thrombosis: The formation of a blood clot in a deep vein that blocks the blood flow, most likely in a leg, causing possible swelling, pain, warmth in the area and unnatural skin color, even a few years after the initial clot; blood clots can cause strokes or heart attacks if blood flow to the brain or heart is blocked
• Pulmonary embolism: The potentially lethal blockage of blood flow in the lungs because a blood clot from a deep vein broke off and traveled there, causing possible difficulty breathing, anxiety, chest pain, dizziness, racing heartbeat, coughing blood and perspiration
The Israeli study was significant enough to prompt the FDA in December 2012 to convene two panels of outside experts (Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee). The FDA panels after reviewing 10 studies voted 15 to 11 that the benefits of birth control with drospirenone outweigh accompanying risks.
Watchdog groups, particularly California Watch and the Project on Government Oversight, question the closeness of this vote, citing potential conflicts of interest. In particular, four of the panelists had historically close professional ties to the manufacturer, Bayer, or to a generic manufacturer, Barr Laboratories (part of Teva Pharmaceuticals). The four in question all voted in support of Yaz and similar medications and they deny any improper influence.
The combined panel did recommend stricter safety labeling for drospirenone-containing products, however. Already, women in San Francisco who have been injured by Yaz have begun to initiate lawsuits against its manufacturer, Bayer, for defective product injuries.
Until the controversy is settled, experts recommend that women using any oral contraceptive with drospirenone talk to their doctors about the risks and proceed with particular caution if other risk factors are present like smoking, obesity, older age or high blood pressure. Evidence suggests that it is a good sign if a patient has been on Yaz or an equivalent for a significant time without developing blood clots.
If you have suffered a blood clot while taking an oral contraceptive with drospirenone, discuss your situation with a personal injury attorney with experience in defective medications to learn about your rights and potential legal remedies.