FDA warns 53 websites to stop marketing illegal opioids
The FDA announced today that it sent warning letters to nine online networks that operate 53 websites ordering them to stop illegally marketing “potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone” according to a press release.
These companies are in violation of the Federal Food, Drug and Cosmetic Act, and those who fail to correct the violations indicated in the warning letters may be subject to product seizure or injunction, or other enforcement action, the FDA stated.
The release also stated that FDA-approved tramadol and oxycodone carry boxed warnings that indicate that the drugs carry a significant risk for serious or life-threatening adverse effects such as the potential for addiction, abuse, breathing problems, coma, death, misuse, and neonatal opioid withdrawal syndrome.
“The internet is virtually awash in illegal narcotics and we’re going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales,” Scott Gottlieb, MD, said in a press release.
“Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives,” he added, noting the warning letters are one of several FDA initiatives that seek to stem the tide of the opioid epidemic.
The online networks receiving warning letters include AnonShop, Eassybuyonline, Instabill ECS-Rx, Medstore.biz, One Stop Pharma, RemedyMart, RxCash.Biz, TramadolHub and XLPharmacy. The companies have 10 working days to tell the FDA how they are addressing the agency’s concerns, according to the release.
“No one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription,” Donald D. Ashley, the FDA’s director of the Office of Compliance in the Center for Drug Evaluation and Research, added in the release.
Disclosure: Gottlieb is FDA commissioner, Ashley is director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.