FDA Updates Blood Clot Risk On Labels Of Yaz and Yasmin Birth Control Drugs
The Food and Drug Administration announced today that that newer generation birth control pills, including Bayer’s Yaz and Yasmin, which contain the hormone drospirenone may be associated with a higher risk of blood clots, and will include this information on updated labels for Yaz and Yasmin.
The revised labels will note, as reported by Law360, that some studies showed as much as a three-fold increase in the risk of blood clots for birth control pills containing drospirenone compared with products containing other synthetic versions of the female hormone progesterone, while other studies found no added risks, the FDA said.
An FDA-funded study published in October found women who took drospirenone-containing birth control pills were about 75 percent more likely to suffer from potentially fatal venous thromboembolism and similar conditions.
The study, which surveyed more than 835,000 birth control users, said the risk was higher among 10- to 34-year-olds, and that a spike in risk occurred for women using the drug for less than three months. The FDA said the study results provided “another positive finding to the increasing body of evidence linking drospirenone to increased risks” of blood clots relative to standard estrogen pills.
In December, an FDA panel recommended that Bayer revise the labels on its Yaz and Yasmin contraceptives to highlight the increased blood clot risks, with a majority of the the 26 panelists voting that the drugs’ labels did not contain enough warning to stress their increased risks of serious side effects including deep vein thrombosis or the formation of a clot in a deep vein.