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FDA Warns Health Officials About Counterfeit Cancer Drug

Discussion in 'Pharmacy' started by Egyptian Doctor, Feb 17, 2012.

  1. Egyptian Doctor

    Egyptian Doctor Moderator Verified Doctor

    Mar 21, 2011
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    The FDA announced on Tuesday that a counterfeit version of the drug Avastin has made its way into the U.S. market. Doctors, hospitals, and pharmacists are being urged to check their supply of the drug to make sure it was manufactured by Roche Group partner Genentech, the maker of the real Avastin.

    What is Avastin?

    Avastin is a "designer drug" created to treat cancer by isolating a protein known as vascular endothelial growth factor, or VEGF, according to Genentech. VEGF helps the body create new blood vessels, which in a person with cancer, can help feed the cancerous cells. By blocking VEGF, Avastin theoretically can "starve" cancer cells and kill them off, according to NPR.

    Avastin has only been approved to help treat certain kinds of cancers, including colorectal, brain, kidney, and lung cancer. It was initially approved late last year for treating breast cancer as well, but the FDA withdrew the approval while it is re-evaluating the drug's effectiveness in treating advanced cases of the disease.

    How did the FDA find out about the counterfeit?

    CNN reports that the FDA tracked purchases made from Quality Specialty Products, which in the U.S. appears to also go under the moniker Montana Health Care Solutions. The company is alleged to have been sourcing counterfeit drugs from overseas distributors and then selling them to U.S. practitioners.

    Genentech themselves tested the suspected counterfeit version of the drug and found it to be not merely repackaged but fraudulent. Some 19 different potential buyers have been identified. The FDA warned all of them individually about the counterfeit drug before releasing a more general press statement on Tuesday.

    Is the counterfeit version dangerous?

    Yes, in that it is missing the active ingredient bevacizumab, the key component in the real Avastin medication. Therefore, anyone who has been treated with the counterfeit would not have been getting needed cancer therapy. Roche and Genentech released a statement on Tuesday giving details on how to identify fake medications, as well as warning practitioners that the counterfeit should not be considered either safe or effective.

    Does the FDA know if anyone has actually been given the counterfeit?

    Not at this time. The path of the counterfeit drug once it hit American shores is still being investigated, according to MSNBC. Because the agency is still unsure just how much of the counterfeit was purchased and distributed, the FDA hasn't been able to determine whether anyone was actually administered the faux treatment.



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