Bayer Finally Adds New Safety Warning to Pill Label

By Susan Brinkmann, OCDS
Staff Journalist

After more than 50 women, some as young as 17, lost their lives to the trendy new birth control pills Yaz and Yasmin, the manufacturer has finally added new warning information to the product label. 

MSNBC is reporting that in cooperation with the Food and Drug Administration (FDA), Bayer Healthcare has added the new labeling to make it similar to other oral contraceptives, although many believe this isn’t nearly enough.

Yasmin and its sister drug, Yaz, are different from other combined hormonal birth control pills in that they contain drospirenone, a progestin that is unlike other progestins available in the United States. Pills containing drsopirenone were never marketed in the United States before Bayer introduced Yasmin in April 2001, followed by Yaz in 2006.

According to one lawyer, Janet G. Abaray, who represents a woman who suffered a stroke after taking Yasmin, studies done prior to FDA approval indicate that drospirenone has more dangerous side effects that other progestins. Specifically, drospirenone causes an increase in potassium levels in the blood which can lead to a condition known as hyperkalemia if the potassium levels become too high. Hyperkalemia can cause heart rhythm disturbances which can be fatal if left untreated.

Besides the risk of blood clots, heart attack and stroke, other side effects of drospirenone include liver damage, depression or emotional changes, migraines, breast lumps, high blood pressure, high cholesterol and signs of allergic reaction including unexplained rashes, hives, itching, unexplained swelling, wheezing and difficulty breathing or swallowing.

“The drug companies have known [about the adverse effects] for some time,” Abaray said in an article appearing in the July 2009 issue of the National Law Journal, “and they have not warned the doctors or their patients.”

Instead, Bayer has been investing millions in trendy ad campaigns that promote the drug to women under 35. The campaign resulted in $1.8 billion in worldwide sales in 2008.

However, the boom in sales has been tempered by conflicts with the FDA. Last October, the FDA sent a warning letter to Bayer citing the company for running false and misleading television ads about Yaz. Aside from minimizing serious risks associated with Yaz, the ads overstated the drug’s efficacy and promoted its use for conditions such as premenstrual syndrome for which it has not been approved.

Bayer agreed to spend $20 million on a corrective advertising campaign.

Even though the company admits that 74 lawsuits have been brought by women who say they developed serious health problems after taking Yaz or Yasmin, Bayer continues to defend the safety of Yaz and Yasmine.

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