Warning labels on drugs alert users to potentially harmful effects and that even a prescribed drug can actually be a dangerous drug. The Federal Drug Administration (FDA) recently publicized that Bayer, a major drug manufacturer, did not warn users sufficiently about the dangers of using Yaz, Yasmin or Ocella. These drugs are prescribed for birth control as an oral contraceptive. Warning labels failed to include important information about the possibility that users could develop blood clots and complications that may result, such as a stroke or heart attack.
The FDA ordered Bayer to label Yaz with stronger warnings; over 10,000 plaintiffs have already filed lawsuits against that drug manufacturer. This new announcement could lend credibility to lawsuit claims that the manufacturer failed to adequately warn users about a potentially dangerous drug. Yaz has been marketed since 2006, and it is just one of few that contain a synthetic hormone drospirenone.
It quickly became one of the most popular contraceptive pills available; but now sales have dropped off significantly in light of new information and lawsuit publicity. A similar product defect action resulted in Pfizer recalling over 1 million packets of their birth control pills, Lo/Ovral-28 or generic norgestrel/ethinyl estradiol.
Complications from blood clots include pulmonary embolism, deep vein thrombosis and other life-altering problems. Birth control pills usually contain hormones, but Yaz studies showed as much as a 75 percent increase of risk, including devastating strokes. Stronger label warnings will undoubtedly save lives in the future just by being included with the prescribed drug.
Source: Washington Post, “Pfizer recall the newest troubling development around birth control,” Elizabeth Flock, Feb. 21, 2012