Wednesday, February 10, 2016

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."

Staff Writer
We encourage respectful comments but reserve the right to delete anything that doesn't contribute to an engaging dialogue.
Help us moderate this thread by flagging comments that violate our guidelines.

Comment policy: comments are intended to be civil, friendly conversations. Please treat other participants with respect and in a way that you would want to be treated. You are responsible for what you say. And please, stay on topic. If you see an objectionable post, please report it to us using the "Report Abuse" option.

Please note that comments are monitored by staff. We reserve the right at all times to remove any information or materials that are unlawful, threatening, abusive, libelous, defamatory, obscene, vulgar, pornographic, profane, indecent or otherwise objectionable. Personal attacks, especially on other participants, are not permitted. We reserve the right to permanently block any user who violates these terms and conditions.

Additionally comments that are long, have multiple paragraph breaks, include code, or include hyperlinks may not be posted.

Read 0 comments
comments powered by Disqus
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

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

Reach David at or 215-854-4506.

David Sell Staff Writer
Also on
letter icon Newsletter