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Yaz, Yasmin Need Stronger Blood Clot Info, FDA Advisors Say

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Yaz, Yasmin and similar birth control pills need stronger blood clot information, according to the U.S. Food & Drug Administration (FDA).

Advisers to the health agency issued a recommendation that labels for the popular, newer generation oral contraceptives, including Yaz and Yasmin, indicate that the drugs may put women at increased risks for dangerous blood clots. Yaz and Yasmin contain drospirenone, a controversial progestin that lawsuits allege has led to serious side effects, including deep vein thrombosis and pulmonary embolism, as well as heart attack, stroke, and gall bladder disease.

Generally, oral contraceptives do place women at increased risks for blood clots; however, a number of studies have indicated Yaz, Yasmin, and other drospirenone-containing birth control pills put women at even higher increased risks for dangerous clots, noted Reuters. However, other studies have produced conflicting results.

The FDA scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss newer generation birth control pills. In a 21-to-5 vote yesterday, the expert advisors agreed that the current—often perceived as rather confusing—label does not fully explain the risks and benefits of these pills to physicians and patients, said Reuters.

“(The label) is incredibly hard for physicians to read and if we think that patients are reading these and understanding these before making their decisions, we’re delusional,” said Dr. Peter Kaboli, a panel member and associate professor of internal medicine at the University of Iowa Caver College of Medicine, wrote Reuters.

The FDA recently reported that its study revealed that women taking drospirenone pills were 75% likelier to suffer from blot clots versus women taking older generation oral contraceptives. According to a prior Reuters report, that risk was even higher in women younger than age 35 who took Yasmin.

“Because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” the FDA reviewers said in a briefing document released prior to yesterday’s meeting.

The panelist were reluctant to seek significant label changes due to the conflicting study results, said Reuters; however, panel members did note that the studies that found Yasmin to be as safe as other birth control pill were sponsored by Yasmin’s maker. “I found that disturbing,” said Dr. Maria Suarez-Almazor, a professor at the University of Texas MD Anderson Cancer Center. Bayer’s Yasmin was the first drospirenone-containing contraceptive approved in the United States in 2001.

“This language goes heavily toward the positive side and is dismissive of conflicting
results,” said Jacqueline Gardner, a University of Washington professor. “I think that needs to be corrected,” Reuters reported.

Concerning current labeling, “Most people only see the watered-down label … We know that labels just don’t change behavior,” said Cynthia Pearson, executive director of the consumer advocacy group, National Women’s Health Network, according to Reuters.

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