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Yaz, Yasmin Could Soon Have Stronger Blood Clot Warnings

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As health regulators consider reported side effects from new generation birth control pills, Yaz and Yasmin could soon be mandated to contain stronger blood clot warnings. The U.S. Food & Drug Administration (FDA) is currently conducting a review of Yaz and Yasmin safety.

The FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for this Thursday to discuss Yaz, Yasmin, and similar, new generation birth control pills. Evidence indicates that these pills may be putting women at increased risks for dangerous blood clots, including deep vein thrombosis and pulmonary embolism, as well as heart attack, stroke, and gall bladder disease.

Yaz and Yasmin contain drospirenone, a controversial progestin. These and other drospirenone-containing oral contraceptives, are being looked at by the FDA, and its advisors, in a comparative review. According to Reuters, agency staff reviewed studies comparing these pills to older generation pills and the data revealed conflicting information on a link between drospirenone-containing pills and blood clots; however a link could also not be ruled out and, because of that, a new label might be called for, said Reuters.

“Because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” said the reviewers, wrote Reuters. This finding was released in advance of the external panel meeting scheduled to convene and vote tomorrow.

Older generation oral contraceptives contain estrogen and progestin, hormones that block ovulation and sperm, explained Reuters, noting that this combination can also increase the likelihood for blood clots, and that that likelihood increases as a woman ages.

A growing body of research has revealed that an increased risk of dangerous blood clots—venous thromboembolisms (VTEs)—have been linked to use of Yaz, Yasmin, and other newer generation drospirenone-containing contraceptives. Last month, the FDA issued a warning about drospiernone-containing oral contraceptives, stating that these drugs increase blood clot risks by 74% versus older oral contraceptives.

Reuters pointed out that similar conclusions were reached concerning Johnson & Johnson’s Ortho Evra contraceptive patch, which will be discussed by FDA advisors on Friday, said Reuters. Ortho Evra does not contain drospirenone.

Over 10,400 individual lawsuits have been filed over Yasmin and Yaz in the United States; that, in Canada, at least one law firm filed a class-action lawsuit against Bayer over Yasmin and Yaz use in Canada, and that thousands of U.S. lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently waiting to be heard before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.

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