FDA warns 21 more websites to stop marketing illegal opioids
The FDA announced today that it sent warning letters to four more online networks that operate 21 websites ordering them to stop illegally marketing and selling “potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol,” 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 legal enforcement action, the FDA stated.
The release also stated that FDA-approved tramadol carries a boxed warning that indicates that the drug is associated with a significant risk for serious or life-threatening adverse effects, such as addiction, abuse, breathing problems, misuse, neonatal opioid withdrawal syndrome, coma and death.
“The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis,” Scott Gottlieb, MD, FDA Commissioner, said in the release. “Cutting off this flow of illicit internet traffic in opioids is critical, and we’ll continue to pursue all means of enforcement to hinder online drug dealers and curb this dangerous practice.”
The online networks receiving warning letters include CoinRX, MedInc.biz, PharmacyAffiliates.org and PharmaMedics. The companies have 10 working days to tell the FDA how they are addressing the agency’s concerns, according to the release.
This announcement builds upon the FDA’s previous actions to combat the opioid crisis, including the issuance of a similar series of warning letters to nine networks and 53 websites in June.
Disclosure: Gottlieb is employed by the FDA.