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Paul Kiesel
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FDA Warns Bayer Over Quality Control Issues, Drug Ingredients

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WASHINGTON — U.S. health regulators have warned drugmaker Bayer over quality control issues at a plant that makes the key ingredient in Yaz and other popular birth control drugs.

In a warning letter posted online Tuesday, the Food and Drug Administration said its inspectors uncovered testing problems at the company’s plant in Berghamen, Germany, during a March visit.

FDA inspectors said the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results.

Bayer shipped eight drug batches to the U.S. that were tested using the method, which the FDA does not accept.

The drug ingredients included drospirenone, which is used in the popular birth control pills Yaz and Yasmin. Those products were the company’s top-selling pharmaceuticals last year, with global sales of $1.8 billion.

After reviewing all drug batches shipped to the U.S. between 2007 and 2009, Bayer responded to the FDA in an April 7 letter that concluded "the quality of these batches was not affected."

But the FDA responded in its own letter last month, disagreeing with Bayer’s "rationale and conclusion."

*Read more at: http://www.huffingtonpost.com/huff-wires/20090915/us-bayer-fda-warning/

**Also, anyone who has been adversely affected due to taking these prescription drugs should get in touch with Helen Zukin. Ms. Zukin recently retained a client, a young woman, who unfortunately suffered from a stroke, after only taking Ocella (generic version of Yaz) for a month.