Some of GlaxoSmithKline’s Antiretroviral Drug Ziagen Mislabeled as Combivir; FDA Opens Investigation
At least four sealed bottles of GlaxoSmithKline's antiretroviral medication Ziagen were improperly labeled and sold as Combivir, leading the FDA to open an investigation into possible counterfeiting, the Washington Post reports. Mislabeled bottles were found in California, Connecticut, Maryland and Florida by patients and pharmacists who noticed that the pills looked different. Although no patients have been harmed, the FDA is monitoring adverse event reports for any possible increase in side effects among patients taking the drugs, the Post reports (Kaufman, Washington Post, 5/11). About 5% of patients taking Ziagen may be at risk for severe allergic reactions and those who thought they were taking Combivir would not have been notified of the risk. Any "unintentional switch" in medications could lower the effectiveness of drug therapy, creating the potential for drug-resistant virus to develop ( AP/New York Times, 5/11). GlaxoSmithKline spokesperson Mary Anne Rhyne said an internal investigation concluded that the error did not occur within the company, leading the company to believe the counterfeiting is part of a "very sophisticated drug diversion and relabeling scheme" that occurred somewhere in the distribution system (Washington Post, 5/11). The FDA's criminal investigations unit is looking into the situation (AP/New York Times, 5/11). "If it didn't happen in the manufacturing facility, then it leaves only one possibility -- that it was deliberately done," Mark Goldberger, an official with the FDA's Office of Drug Evaluation, said. Typically, scams involving antiretroviral drugs are meant to defraud the Medicaid system by providing an "improperly" obtained drug in its correct bottle, the Post reports. Although GSK characterized the problem as "isolated and limited in scope," the company is urging patients and pharmacists to "double check" medication (Washington Post, 5/11). Any suspicious bottles should be returned to GSK for further investigation. Patients or pharmacists with questions can call 1-888-825-5249 for more information (AP/New York Times, 5/11).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.