FDA Investigates Counterfeit Drugs, Including AIDS Drug Serostim
The FDA has launched a "high-priority" investigation into four reports of counterfeit prescription drugs -- including the AIDS drug Serostim -- reaching pharmacy shelves, the New York Times reports. The four cases involve three injectable drugs -- Serostim, manufactured by Serono Inc. and used to treat unintended weight loss associated with HIV/AIDS; Nutropin, a growth hormone sold by Genentech; and the cancer drug Neupogen, sold by Amgen. The Times reports that counterfeiters may have targeted these three drugs because they are relatively expensive; a 12-week course of Serostim costs $21,000. In addition, Serostim and Nutropin may be popular among people who "believe the drugs will help them lose weight, build muscle and smooth wrinkles," and some Web sites even market the drugs in this manner, selling them without requiring a prescription. The FDA has not determined whether the counterfeit drugs were manufactured in the United States or abroad, and the Times notes that the drugs "appear to be coming through networks that operate largely beyond the reach of regulators." The drugs typically enter the "gray market" through individuals or small businesses who claim they are purchasing the drugs for nursing homes or other institutions that often receive "steep discounts" from pharmaceutical companies. Instead, the drugs are then resold between small drug distributors several times, quickly obscuring the drugs' origins.
Serostim Targeted Again
The most recent case of counterfeit Serostim represents the second "fake batch" of the AIDS drug to reach pharmacy shelves (Petersen, New York Times, 6/5). Late last year, Serono received reports of patients who unknowingly purchased counterfeit Serostim in at least six states. Patients using the fake drug reported side effects including skin irritation and redness on the area of the skin where the drug was injected (Kaiser Daily HIV/AIDS Report, 1/23). In May, Serono warned consumers about the possibility of counterfeit Serostim (Kaiser Daily HIV/AIDS Report, 5/18). The Times reports that in the most recent counterfeit drug cases, the fake drugs' labels closely resembled real labels. Counterfeit vials were found to contain either "cheap, generic versions of the drugs" or "clear liquid that contained no active drug ingredient." While some patients experienced "adverse reactions" to the fake drugs, there have been no reports of serious injuries (New York Times, 6/5).