The US Food and Drug Administration (FDA) is warning doctors and other health care professionals that fake cancer drug, injectable Altuzan (bevacizumab), has entered the country. Bevacizumab is approved in the USA as Avastin, and sold by Genentech. Injectable Altuzan (400 mg/16 ml) is approved in Turkey, but not the United States, the FDA informs. The fake product has no active ingredient.
The FDA stresses that buying and administering unapproved or illegal foreign drugs places patients at risk of unsuitable treatments, contamination, and improperly stored and transported goods – in short, it might expose patients to danger.
Patients who are concerned about their treatment following this warning should talk to their health care professionals, the FDA adds.
On February, 14th, 2012, the FDA warned about cases of fake Avastin, which may have been bought by some practices and clinics. Avastin, administered by injection, is used to treat cancer. The Agency warned that the counterfeit Avastin contained no active ingredient. The FDA wrote to 19 medical practices that had purchased the possibly counterfeit drug. Avastin is manufactured outside the USA by Roche, a Swiss multinational pharmaceutical company. Approved Avastin is made and sold within the USA by Genentech, which is part of Roche.
The FDA says the fake Altuzan entered the USA through foreign sources, namely: Richards Pharma (Richards Services), Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI). Warwick Healthcare Solutions is registered in the UK, and is said to distribute pharmaceuticals. Richard’s Pharma is also registered at the same address. Ban Dune Marketing Inc, which was based in La Jolla, California, closed in August 2011, state corporation records show. It appears that the three distributor names, are in fact, the same company.
The FDA says that many, and possibly all of the products distributed by this company are not FDA approved. The FDA adds that it is unable to ensure that the distribution, warehousing, or manufacture of these illegal products follow US regulations.
In its website today, the FDA wrote:
“Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA. The products should be retained and securely stored until further notice by the FDA.”
Pictures of the counterfeit drugs are shown below:
The FDA is asking people to report suspected fake products obtained from the companies mentioned above to 1. Telephone: 800-551-3989 (FDA Office of Criminal Investigation). 2. FDA Office of Criminal Investigation website. 3. DrugSupplyChainIntegrity@fda.hhs.gov
Written by Christian Nordqvist