YAZ LABEL UNDER SCRUTINY AT RECENT PANEL MEETING
December 2011Advisers to the Food and Drug Administration met on December 8, 2011 to review the science behind Yaz, Yasmin and its class of birth control pills. The advisers panel voted that the drugs’ prescribing label should be changed to better reflect blood clot risks.
The advisers voted 21-5 that the information labels for the class of medications should be changed to more clearly reflect the potential for blood clots as a side effect of the drugs.
The FDA does not have to follow the panels’ recommendations.
The clarity of the language and the way the label communicates the information formed part of the discussion about how the label should be updated to warn women who take the drug types at issue.
Drospirenone is similar to the naturally occurring female hormone progesterone.
The FDA acknowledges that the newest generation birth control pills may raise the risks of blood clots.
Yaz was approved for sale in the U.S. in 2006 and has a lower does of estradiol than Yasmin, which began sales in the U.S. in 2001.
Yas and Yasmin and similar medications combine drospirenone, a synthetic versions of the female hormone progesterone, with estradiol, a form of the female hormone estrogen.
Bayer faces many lawsuits over injuries allegedly caused by the medications.
Some womens’ health advocates are so concerned by Yaz and Yasmin that they believe the medications should be taken off the market since in their opinion there are safer birth control medication options available.