Lawsuits pile up over popular birth control pill


September 15, 2013|By Julie Deardorff, Chicago Tribune reporter
  • Maggie Yunker, 23, at her home in Peotone. Yunker suffered a stroke a year after she started taking the birth control pill Yaz and sued Bayer.
Maggie Yunker, 23, at her home in Peotone. Yunker suffered a stroke a year after she started taking the birth control pill Yaz and sued Bayer. (Zbigniew Bzdak/Tribune Photo)




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.


The company, which expects additional lawsuits like Yunker's, has admitted no fault.


"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."


"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."


"I have no problem prescribing these medicines," said Dr. Barbara Soltes, a reproductive endocrinologist and associate professor at Rush University Medical Center who conducted industry-funded research on drospirenone before it came to market.

Calling the pills "very safe," Soltes said she believes the increase in reported adverse events and litigation is because of the pills' popularity. The FDA, meanwhile, said media coverage of the lawsuits likely also has inspired people to file adverse event reports.

Still, Soltes acknowledged, the elevated potassium levels associated with drospirenone can put women who have liver or kidney issues at risk for serious heart problems.

"I monitor electrolytes once a year and advise women who are having problems with breathing, chest pain or pain in the lower extremities to notify us right away," she said.

Oral contraceptives, the most popular form of birth control in the U.S., work by altering a woman's hormone levels. Most use a combination of the hormones estrogen and progestin to stop ovulation. Well-known side effects include bloating, irregular bleeding, headaches, breast tenderness and nausea.

But estrogen can play a role in blood coagulation; it's well known that increasing levels of the hormone by taking oral contraceptives can raise the risk of stroke and blood clots. Smoking, obesity and family history can all contribute to clots, which can cause heart attacks, strokes and blood vessel blockages.