The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that a counterfeit form of Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) has been discovered in three US pharmacies.
According to the company, no adverse events have been reported in connection with the fraudulent drugs. The company continues to work with the US Food and Drug Administration (FDA) to investigate the fraud, and to prevent additional fakes from getting into consumers’ hands.
“Counterfeit medicines can place patient health at risk, and Janssen has implemented various approaches to combat counterfeiting. This includes working with stakeholders to secure the distribution system and implementing special packaging and printing techniques that make counterfeit product more difficult to produce and easier to identify,” the firm said in a statement. “Patients and healthcare providers can be assured that Janssen is doing everything possible to address this issue and reduce the risk to patients as a result of this illegal act.”
Symtuza is indicated for treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing 88 pounds (40 kg) or more, with no prior antiretroviral treatment history or who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months, and have no known substitutions associated with resistance to darunavir or tenofovir.
“Nothing is more important to Janssen than ensuring the health and safety of the patients who rely on our medicines,” said Rick Nettles, vice president of U.S. medical affairs, infectious diseases and vaccines for Janssen Therapeutics with Janssen Scientific Affairs. “We have begun informing prescribers and pharmacists about the situation and are providing guidance on how to identify authentic Symtuza tablets. We are also enlisting the help of the strong HIV-patient advocacy community to ensure patients receive this information in a timely manner.”
While no adverse events have been reported to date, Janssen advises that it is “critically important” that patients duly receive the authentic medication prescribed to them. The actual Symtuza tablets are yellow to yellowish-brown, capsule-shaped, film-coated tablets debossed with “8121” on one side and “JG” on the other side.
Consumers or businesses that notice Symtuza tablets that don’t match the description are advised to contact the FDA Office of Criminal Investigations, www.fda.gov/OCI. Patients are advised to contact their prescriber and pharmacy as soon as possible.