FDA Warns Public Against Counterfeit Anti-Dengue Drug

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against the purchase and use of the counterfeit version of the dengue vaccine Qdenga. In an advisory, the FDA said the QdengaTM Dengue Tetravalent Vaccine (Live, Attenuated) powder for injection is not yet registered with the agency. “The application for registration is still on process. Therefore, all healthcare professionals and the general public are hereby warned as to the availability of this counterfeit vaccine in the market,” FDA said. Health experts said the application for registration of Qdenga was submitted to the FDA on April 20, 2023. Qdenga is the second dengue vaccine to be prequalified by the World Health Organization, following Sanofi’s Dengvaxia in 2020. According to the FDA, the use of the counterfeit product may pose serious health risks when administered. It warned establishments and outlets against selling or dispensing the fake vaccine product, as it directed all local government units and its law enforcement agencies to ensure that the fake products are not sold or made available in their localities or areas of jurisdiction. This warning highlights concerns regarding the safety and efficacy of pharmaceutical products in the Philippines. Vaccines, especially those aimed at combating public health threats like dengue, require stringent quality control and regulatory approval. The circulation of counterfeit medicines not only endangers patients' health directly but also erodes trust in legitimate healthcare systems. Counterfeiting and illegal sales of medicines have been a persistent challenge in the Philippines, with the FDA continuously enhancing its monitoring and enforcement efforts.