By Yardena Schwartz
The U.S. Food and Drug Administration is urging patients who were treated with the popular cancer drug Avastin to contact their physicians, as the agency investigates a counterfeit version of the product. Avastin is the best-selling cancer medication in the country, according to Associated Press, and is used to treat brain, colon, kidney and lung cancers.
The counterfeit drug, made without the key ingredient in Avastin, was distributed to health care centers in the U.S., but it’s unclear how long the fake drug has been on the market, where it originated, what it actually contains, or how much of it is in circulation, Shelly Burgess, FDA spokesperson, told NBC News. Contents of the counterfeit vials are still being analyzed.
“We are still evaluating the situation,” Burgess said. “It’s evolving, so there is a lot we still don’t know.”
Avastin was the 14th best-selling drug in the U.S. in 2010, according to IMS Health, the Associated Press reported. It works by choking off the blood supply that feeds tumors.
A spokesperson for Genentech told NBC News that it is impossible to track exactly how many patients are treated with Avastin, but said that company sold 5 million valves of the product last year.
Only a limited number of patients could have been given the counterfeit medication, Burgess said. "This affects a small subset of cancer patients in the U.S. -- only those whose doctors were obtaining their products from illegitimate sources of non-FDA approved drugs."
The FDA has sent letters to 19 medical practices it believes may have purchased fake versions of the drug, most of which are located in California. Genentech, which makes Avastin and is owned by Roche, is warning doctors and hospitals that the counterfeit version lacks the active ingredient in their drug and should not be used.
Labels of FDA-approved Avastin are printed with the “Genentech” name, along with a six-digit lot number with no letters. According to the FDA’s statement, the fake version is labeled with Roche as the manufacturer, and has the lot numbers, B6010, B6011 or B86017.
Although the origin of the counterfeit version is unknown, the FDA told NBC News the drug is produced overseas and was distributed in the United States by a foreign supply company called Quality Specialty Products. The company also operates under the name Montana Health Care Solutions.
Burgess said that the Medicines and Healthcare products Regulatory Agency in the UK first alerted the FDA to the counterfeit operation on February 7th.
In the past, problems with counterfeit drugs have been mostly in poor countries with looser regulations, but now, as more medications are being made overseas, authorities are afraid more will arrive into the U.S.
“We do know there are counterfeits continuing to try and make their way onto the U.S. supply chain," Connie Jung, an associate director in the Food and Drug Administration's office of drug security told the Associated Press.
For the most updated information on the investigation, visit the FDA’s Web site.
The Associated Press contributed to this report.
For more on this story:
- Fake Avastin raises counterfeit drug trade concerns
- Roche warns of alien counterfeit cancer drug in U.S.