FDA takes action against 53 sites peddling unapproved opioids

The US drugs regulator has issued warning letters to nine online networks operating 53 websites that they must stop selling illegal opioid medications, including tramadol and oxycodone.

Companies that fail to desist from selling potentially dangerous, unapproved and misbranded versions of the drugs “may be subject to enforcement action, including product seizure or injunction,” says the FDA.

This is particularly concerning considering that tramadol and oxycodone carry boxed warnings, which the agency notes is its most prominent warning, indicating that the drugs carry a significant risk of serious or even life-threatening adverse effects.

The action comes at a time when opioid abuse has reached epidemic proportions in the US, with more than 64,000 opioid overdose deaths last year, according to Drug Enforcement Administration (DEA) figures. Worryingly, around a third of those deaths turned out to be caused by counterfeits containing fentanyl and other synthetic opioids, that are far more dangerous than the drugs they mimic.

The networks receiving warning letters include:

• AnonShop
• Eassybuyonline
• Instabill ECS-Rx
• Medstore.biz
• One Stop Pharma
• RemedyMart
• RxCash.Biz
• TramadolHub
• XLPharmacy

“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,” said FDA Commissioner Scott Gottlieb.

“Consumers who use these products take significant risk with their lives. The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids,” he added.

FDA is also planning to hold a summit with Internet stakeholders on June 27 at its White Oak Campus in Springfield, Maryland, to find new ways to work collaboratively with them to crack down on online illegal sales.