FDA Warns 21 More Websites that Market Unapproved Opioids
By Mark Terry
The U.S. Food and Drug Administration (FDA) warned four online networks that operate 21 websites selling opioids online. The warning indicates they were “illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warnings letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.”
The FDA notes that the opioids being sold on these websites might be counterfeit, contaminated or expired. Often they are misbranded and unapproved new drugs. They also warn that in addition to health risks, they can pose consumer risks such as credit card fraud, identity theft and computer viruses.
“The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis,” stated FDA Commissioner Scott Gottlieb. “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 deals and curb this dangerous practice. Today’s effort builds on previous actions against the illegal online sale of opioids, for a total of 13 warning letters to more than 70 websites just this summer. The FDA remains resolute in our promise to continue cracking down on these networks to protect the public health. We have more operations underway, and additional actions planned. We are also working closely with legitimate Internet stakeholders, including leading social media sites, in these public health efforts.”
The agency also points out that the tramadol sales are particularly worrying because FDA-approved tramadol carries a boxed warning, which is its most prominent warning, concerning serious and potentially life-threatening side effects. “The boxed warning for tramadol addresses 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, tramadol’s use may result in coma or death.”
The four networks cited were CoinRX, MedInc.biz, PharmacyAffiliates.org and PharmaMedics. They need to respond within 10 working days and respond to the letters’ specified corrective actions, or there may be legal enforcement action.
The warnings stated, in part, “Offering unapproved opioids for sale is particularly concerning given their potential for abuse and dependency, especially amid the growing opioid epidemic in the U.S. On average, 115 Americans die every day from an opioid overdose. In 2016, opioids killed more than 42,000 people, surpassing even the number of deaths resulting from traffic accidents in the U.S.”
In June, the agency sent warning letters to nine online networks that operate 53 websites. The networks at that time were AnonShop, Eassybuyonline, Instabill ECS-Rx, Medstore.biz, One Stop Pharma, RemedyMart, RxCash.Biz, TramadolHub and XLPharmacy.
In a statement at the time, Donald D. Ashley, the FDA’s director of the Office of Compliance in the Center for Drug Evaluation and Research, said, “No one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription.”