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Home / Uncategorized / FDA label change for Drospirenone regarding...

FDA label change for Drospirenone regarding Blood Clots

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Women to take the birth control drug Yaz or Yasmin should be aware of the new labeling requirements. FDA recently completed its review of observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone Drospirenone is the active drug in some birth control prescriptions including Beyaz Safyral, Yasmin and Yaz. Based on the review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

Some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots. The FDA is requiring the label on these drospirenone-containing products to disclose this. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk

The safety communication states:
“The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.”

The FDA is encouraging women to talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use. If you or someone you love has experienced serious or fatal blood clots or other complications associated with the usage of Yaz or Yasmin, speak to a drug injury attorney today by calling 1-855-566-4648 or filling out the Longo Legal contact form.

Source: FDA Drug Safety Communication; 04/10/2012

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