by Julie Deardorff, Chicago Tribune reporter
September 15, 2013
FDA says contraceptives containing drospirenone may pose greater blood clot risk; industry-funded studies, some physicians say drugs are very safe
Peotone’s Maggie Yunker had been taking birth control pills for a year when her doctor suggested switching to a brand that also could clear up acne and ease some aggravating symptoms related to her period.
Yunker was sold. But a year later, the 20-year-old suffered a life-altering stroke after multiple blood clots formed, broke free and lodged in her brain.
Though all oral contraceptives slightly increase the chance of developing blood clots in the legs and lungs, Yunker was taking Yaz, part of a newer generation of pills that the U.S. Food and Drug Administration says may pose a greater risk than similar types of birth control.
The increase in risk is still small, and birth control pills are generally considered so safe and effective that some doctors’ groups advocate selling them over the counter.
But Yaz and other pills containing the hormone drospirenone have drawn a flood of litigation over reports of deaths, strokes, pulmonary embolisms, gallbladder disease, elevated potassium levels and other problems. Bayer Healthcare Pharmaceuticals, the leading manufacturer of the drugs, as of July had settled the claims of 6,760 U.S. plaintiffs for a total of $1.4 billion, including $237,000 to Yunker.
The company, which expects additional lawsuits like Yunker’s, has admitted no fault.
Critics have urged the FDA to recall pills with drospirenone, arguing that safer and equally effective choices are available. At the very least, they say, women need more information about the potential dangers to help them make informed decisions.
“I didn’t think anything bad could happen, especially since a doctor was giving it to me,” Yunker said. “Any medicine has risk factors, but when you’re 20 you don’t think about it.”
Last year, after reviewing the studies on the risk of blood clots, the FDA changed the prescription information for birth control pills containing drospirenone. The revised labels explain that the medications may be associated with a higher risk of blood clots than contraceptives containing other hormones.
“Studies comparing the risk of a blood clot range from no increase to a threefold increase,” it states on Page 5 of the 33-page document for Yaz.
Some women’s health advocates want a stronger, black-box warning that is more likely to be noticed. The advocacy group Public Citizen, meanwhile, has placed drugs containing drospirenone — including Yaz, Yasmin, Gianvi and Zarah — on its “do not use” list because they “can cause increased blood levels of potassium and (are) no more effective than other oral contraceptives in preventing pregnancy.” On the Internet, people who call themselves “Yaz survivors” post accounts of their experiences.
That class of drugs “shouldn’t be on the market because there are so many safer alternatives,” said Diana Zuckerman, president of the National Research Center for Women & Families. “We can debate how unsafe it is and for whom — more research could obviously clarify that — but there’s really no doubt that it’s not as safe as dozens of other birth control pills.”
Bayer points to at least three industry-funded studies that show no increased risk. After reviewing the safety research, the FDA concluded last year that the benefits of the medication outweigh the risks, and some physicians say the drugs pose no additional dangers when appropriately prescribed.
To view the article in the Chicago Tribune, click here.
A longer version of this article appeared in Med City News.