FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales – Drug Information Update

The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.   Companies who fail to correct the violations, as outlined in the warning letters, may be subject to enforcement action, including product seizure or injunction. Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol and oxycodone, in violation of the Federal Food, Drug, and Cosmetic Act. This is particularly concerning considering that FDA-approved tramadol and oxycodone carry boxed warnings, which is the FDA’s most prominent warning, indicating that the drugs carry a significant risk of serious or even life-threatening adverse effects. The boxed warnings address risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems) and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn babies). In addition, when taken with other central nervous system depressants, including alcohol, their use may result in coma or death. The networks receiving warning letters include: AnonShop Eassybuyonline Instabill ECS-Rx Medstore.biz One Stop Pharma RemedyMart RxCash.Biz TramadolHub XLPharmacy The FDA requested responses from each of the companies within 10 working days. The companies are directed to inform the agency of the specific actions taken to address the agency’s concerns. For more information, please visit: Opioid Websites Warning Letters.