Archive for December, 2011

PANEL RECOMMENDS CHANGES TO YAZ, YASMIN, LABELS

December 2011

Advisers to the Food and Drug Administration met on December 8, 2011 to review the science behind Yaz and its class of birth control pills and voted that the drugs’ prescribing label should be changed to better reflect the blood clot risks to women who take the medications.

The advisers voted 21-5 that the information labels for the class of pills should be changed to more clearly reflect the potential for blood clots as a side effect of the medications.

The FDA does not have to follow the panels’ advice.

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 class of birth control medications.

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.

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 thousands of lawsuits over injuries allegedly caused by the medications.

Lawyers have cited FDA reports on at least fifty deaths of those taking the medications between 2004 and 2008.

Some womens’ health advocates are so concerned by Yaz and Yasmin that they believe the medications should be taken off the market since there are safer options available.