This month's FDA warning is only the most recent regarding fake Altuzan. In February, the Administration issued its first warning, which explained that counterfeit Altuzan does not contain the medicine's active ingredient, bevacizumab. The medical practices that purchased the unapproved drug, and potentially counterfeit Avastin, did so from Quality Specialty Products, also known as Montana Health Care Solutions, a foreign supplier with medicines distributed by Volunteer Distribution in Tennessee. The counterfeit version is labeled as Avastin, the approved form of the drug in the United States.
In its warnings to health care providers, the FDA stresses that "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. 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."
The FDA also notes that none of the unapproved cancer medications received by health care providers from Volunteer Distribution are in shortage in the United States, and that approved versions of the medicines are available in adequate supply to meet current demand. This means that medical practices purchasing the unapproved drugs were likely doing so only to save money.
If a medical provider knowingly treats a patient with an unapproved drug, he or she may be held liable for resulting damages to the patient. A physician or pharmacist may also be responsible for administering a counterfeit drug if he or she should have known it was fake or unapproved. If a wholesaler brought the drug into the United States, the wholesale company may also be liable to injured patients.
