Bayer Healthcare Adds New Warnings to Yaz and Yasmin
Recently, federal regulators have requested that Bayer Healthcare revise its marketing materials for birth control products Yaz and Yasmin, adding new safety information to the drugs’ labels. According to News Inferno, Bayer announced Friday, April 9, 2010 that it would add new “Warning” sections to both drugs to include information about risk of blood clots associated with the drug. The new information came into light after two large, multiyear studies of over 120,000 women who took the contraceptives in the U.S. and U.K.
The Food and Drug Administration (FDA) issued a letter Bayer on April 7: “All promotional materials for your drug product that include representations about your drug product must be promptly revised to make it consistent with the labeling changes approved in this supplement, including any new safety information.”
Bayer had seven days to comply with the directive.
Yaz and Yasmin have been associated with severe health problems, including hyperkalemia, heart arrhythmias, electrolyte imbalance, hyponatremis, stroke, blood clots, embolism, sudden death and more. The drugs are both manufactured with drospirenone, a type of progestin that can elevate the body’s potassium levels, which can result in serious heart and heath conditions.
In the past few years, Bayer Healthcare has faced over 1,000 lawsuits, three putative consumer class action suits in the U.S. and two other class action suits in Canada, regarding personal injury and economic loss claims as a result of taking the drug.
If you have suffered health problems as a result of taking Yaz or Yasmin, you may be entitled to recover compensation. Call 314-322-8515 for a free consultation with an experienced St. Louis injury attorney at Page Law.
