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.
"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.
Overall, "birth control has many health benefits, including a decrease in ovarian and uterine cancer and reduced cramping," as well as a reduction in heavy menstrual flow, Soltes said. But they aren't right for everyone, she said. "Certainly risks will outweigh benefits if given to high-risk women."