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."
Since oral contraceptives were introduced in the 1960s the estrogen doses have been dramatically lowered. The current debate is over the type of progestin the pills contain.
Launched in 2001, Bayer's Yasmin was the first birth control pill to use drospirenone, a new form of progestin. Yaz, a reformulated version of Yasmin, was approved in 2006 as a way to treat mild acne and a severe type of mood disorder in women who also wanted birth control.
Yaz and its cousins are no more effective than older and usually cheaper pills, generally allowing one unplanned pregnancy per year for every 100 women. But for some women, the newer drugs didn't cause the bloating or weight gain that can be a common side effect. By 2008, Yaz was the best-selling birth control pill in the U.S., according to IMS Health, a health care and technology information company. Sales totaled $781 million in 2009.
Yaz's reputation took a serious hit in 2008 after the FDA warned Bayer that its advertising was misleading. The commercials, in which euphoric women sang, "We're Not Gonna Take It," as they kicked and punched words such as "irritability," "moodiness" and "bloating," over-promised benefits, minimized risks and encouraged the use of Yaz in unapproved ways, the agency said.
Bayer denied wrongdoing but agreed to stop running the commercials and, per an unusual FDA request, ran a series of corrective television ads.
"A substantial number of women take the pills for issues such as difficult, irregular or painful periods," said Zuckerman of the National Research Center for Women & Families. "But the benefits of regulating periods do not outweigh the risk of potentially fatal blood clots. ... If a woman wants lighter, more regular periods, she has many pills to choose from."
Sales of Yaz plummeted by 60 percent in 2010. Last year, sales of Yaz were $76 million, according to IMS Health. But a generic version called Gianvi, manufactured by Bayer and sold by Teva Pharmaceuticals, was the No. 4-selling combined oral contraceptive in the U.S. last year, with $146 million in sales and 4.2 percent of a highly splintered market. Bayer's Beyaz, which has added folate, was fifth at $129 million.
As of July, about 5,400 claims of injuries related to Yasmin, Yaz or the generic versions of the drugs (Ocella and Gianvi) were still pending in the U.S., according to Bayer.
The company had been settling claims only for blood clot injuries, based on a case-by-case analysis of medical records. About 2,800 of the unsettled claims involve blood clot allegations, Bayer said.
Then, in March, the company agreed to address alleged gallbladder injuries, again without admitting fault. Bayer said it has set aside $24 million for about 8,800 U.S. plaintiffs who have decided to participate.
The risk of blood clots with any birth control pill is far lower than that associated with pregnancy and the postpartum period. But some advocates say the risk of any pill should be weighed against that of other forms of contraception, not the possibility of pregnancy.
"The comparison ... presumes women's only choices are to use hormonal birth control or to be pregnant," said Elizabeth Kissling, executive editor of re: Cycling, the blog of the Society for Menstrual Cycle Research.
Several large studies, including the FDA-funded research, suggest the risk of a blood clot with pills containing drospirenone is 1.5 times higher than with other hormone-based contraceptives. That means an estimated 10 in 10,000 women on the newer drugs will experience a blood clot, compared with 6 in 10,000 women on older contraceptives, according to the FDA.
Overall, about six other studies show increased risk and three don't, said Dr. Stephen Sidney, lead author of the FDA study and director of research clinics at the Kaiser Permanente Northern California Division of Research. But "interpretation of studies has been complicated by the fact that the ones that don't show any relationship with increased risk are all funded by pharmaceutical companies while the studies that show higher risk are not," he said.
Yunker, of Peotone, said she ultimately spent nearly a month receiving treatment in two hospitals. After she was released, she had such intense head pain and double vision from the clot's location in her brain that she was forced to drop out of cosmetology school, she said.
Today she's working as an aesthetician, is still taking blood-thinning medication and expects lifelong appointments with a neurologist and hematologist. She had no health insurance at the time of the stroke. Forty percent of her settlement went to her lawyers, she said, and she still owes more than $20,000 in hospital bills.
Yunker worries that her double vision will return. She learned during her hospitalization that she suffers from blood disorders. The minute she gets a headache, a feeling of panic sets in.
"I'll be dealing with this for the rest of my life," she said.
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