Wednesday, August 20, 2014
Inquirer Daily News

FDA says more fake Avastin found in U.S.

The FDA warns doctors and health-care facilities about more counterfeit Avastin, the injectable drug used to treat several forms of cancer.

FDA says more fake Avastin found in U.S.

The U.S. Food and Drug Administration said doctors and health-care facilities should be aware that it has seen more counterfeit Avastin, the injectable drug used to treat several forms of cancer.

"Medical practices that purchase and administer illegal and unapproved foreign medications are putting patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous," the FDA said in a statement. "Illegal drugs purchased from foreign sources may not be genuine or meet appropriate quality, safety, and efficacy standards, putting patients at risk and depriving them of proper treatment."

Some of the problem could be that the medicine has no active ingredient. Some of the problem could be bad stuff in the bottle.

Avastin is made by Genentech, which is now part of Roche, which has facilities in the New Jersey towns of Nutley and Branchburg.

Beyond the counterfeit issue, there is also the issue of drugs approved in other countries but not here.

"FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab), an injectable cancer medication, found in the U.S. contains no active ingredient," the FDA statement said. "Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey). On February 14, FDA issued an alert about another cancer drug in U.S. distribution that was purchased from a foreign source and found to be counterfeit.

"Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI). Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. The agency cannot ensure that the manufacture and handling of these illegal products follows U.S. regulations, nor can FDA ensure that these drugs are safe and effective for their intended uses."

David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell
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