Why the FDA Approved Yaz

In April of 2012, the FDA (U.S. Food and Drug Administration) released a Safety Precaution memo regarding Yaz, a birth control pill for women designed by Bayer Pharmaceuticals. The FDA’s serious warning including the following: “The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The main, active ingredient in Yaz is Drospirenone, along with estrogen, and this FDA study was in fact targeted particularly towards the Yaz contraceptive. Researchers now know that this agent, Drospirenone, has a significant potential to cause blood clots in people who regularly ingest it—people like patients of Yaz.

If you have used birth control like Yaz or Mirena and suffered a serious injury as a result, you should consult with our personal injury attorneys to ensure that your rights are protected. You may click here for more details.

So Why Was it Approved to Begin with?

Considering the above information, it is common sense to ask why Yaz was ever approved of by the FDA to begin with. The FDA approved Yaz for use as a birth control pill in 2006, and in 2007 it gained further clearance for use as an acne medication.

Yaz was originally approved in the same way many defective drugs are approved: via the FDA’s now highly criticized 510K Clearance, which is a policy that allows the approval of drugs and products that are similar to previously approved and tested drugs and products. Obviously, this is a faulty method of approving a drug that will be used by potentially millions of people since each drug is, as the facts have it, unique.


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