FDA Requires Labels of Drospirenone Birth Control, Like Yaz, to Include Increased Blood Clot Risk Warning

The requirements levied against Bayer and its popular birth control Yaz became stricter today. The Food & Drug Administration has issued a safety alert regarding birth control that contains drospirenone, like Yaz and Yasmine, saying that they may be associated with a higher risk for blood clots than other progestin-containing pills.

As a result, Bayer must revise all labels of Yaz and Yasmin to include this FDA warning. Specifically, the labels must include that some epidemiological studies reported as high as a three-fold increase in the risk of blood clots while other epidemiological studies found no additional risk.

While the labels being updated is a move in the right direction, the warning is watered down by the second half which acknowledges the studies conducted by Bayer which found no additional risk. As a member of the Yaz Multidistrct Litigation Steering Committee and an attorney representing hundreds of women injured due to Yaz and Yasmin, I have seen the harm this drug has caused thousands of woman first-hand.

Thousands lawsuits have been filed against Bayer over Yaz/Yasmin. More than 267 deaths have been linked to drospirenone-containing pills and similar birth controls, according to an FDA study. Plus, it can cause numerous other serious medical problems like stroke, heart attack, kidney failure and gall bladder problems.

Perhaps the FDA recognized including both study results sends consumers a mixed message because it has also required that the label include a summary of the FDA-funded study of the blood clot risk. The FDA study confirmed that women who take contraceptives that contain drospirenone are 75 percent more likely to suffer serious side effects from blood clots compared to older birth control methods.

While the FDA did not include the summary wording that would go on the label in its wording, hopefully it will be enough for women to fully understand the risks.


Simmons Support Team
Simmons Hanly ConroyWritten by:

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