FDA Warns of Counterfeit Cancer Drugs

FDA Warns of Counterfeit Cancer Drugs

January 16th, 2012 // 1:31 pm @ jmpickett

Shortages of some injectable cancer drugs have created an opening for dangerous unapproved versions of Roche Holding AG’s Herceptin and Amgen’s Neupogen to be sold to clinics and other healthcare providers, U.S. health officials said.

The Food and Drug Administration issued a notice Friday warning providers to avoid direct solicitations from unproven sources and only buy drugs through approved channels.

“Clinics were purchasing unapproved medications as a cost-savings measure,” not because drugs were in short supply, said Patricia El-Hinnawy, a spokeswoman for the agency, in an email.

Record drug shortages in the United States are causing some hospitals and clinics to use less-effective medicines, according to doctors and pharmacists. The FDA has arranged to import foreign versions of life-saving drugs that are in short supply, the agency said.

Unapproved versions of Roche’s Rituxan and AstraZeneca Plc’s Faslodex have also been sold, the FDA said. The quality of such products is often jeopardized, putting patients at risk, the agency said. Though some injectable cancer medications are in short supply, none of the unapproved products are on the shortage list, the FDA said.

“Amgen is aware of and is cooperating with the FDA on investigations related to the illegal importation of Amgen product that is approved for sale in other regions, but unapproved for sale in the U.S. and being sold on the Internet and directly to U.S. clinics,” Mary Klem, a spokeswoman for the Thousand Oaks, California-based company, said in an email.

Pharmacist Group

Reports about sales of non-approved medicines have been brought to the attention of the American Society of Health System Pharmacists, said Bona Benjamin, the Bethesda, Maryland-based group’s director of medication use quality improvement.

“What this is doing is capitalizing on the fear of a shortage and selling drugs that aren’t even in a shortage yet,” Benjamin said in a telephone interview. “I would advise people not to deal with these entities.”

The FDA notice advised clinics to verify the manufacturer or wholesaler where they purchase their products. El-Hinnawy said multiple sources for the unapproved drugs come from the Internet. The agency also cautioned that deeply discounted drugs probably are counterfeit or unapproved.