Aug. 29 (UPI) — The U.S. Food and Drug Administration has ordered the operators of 21 websites to stop selling unapproved versions of opioid medications.
On Tuesday, the FDA announced it added the websites, stemming from four networks, to an original list it announced in June. The networks are eCoinRX, MedInc.biz, PharmacyAffiliates.org and PharmaMedics.
“The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis,” FDA Commissioner Scott Gottlieb said. “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 FDA is increasing its efforts to crack down on the illegal sales, Gottlieb said.
“We have more operations underway, and additional actions planned,” he said. “We are also working closely with legitimate Internet stakeholders, including leading social media sites, in these public health efforts.”
In the warning letters, the FDA noted “these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol, in violation of the Federal Food, Drug, and Cosmetic Act. In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses.”
The products may be may be counterfeit, contaminated, expired or unsafe, the FDA said.
The FDA noted that agency-approved tramadol carries a boxed warning — the FDA’s most prominent warning — because it carries a significant risk of serious or even life-threatening adverse effects. The risks include addiction, abuse, misuse, life-threatening respiratory depression and neonatal opioid withdrawal syndrome. Also, when taken with other central nervous system depressants, including alcohol, the drug’s use may result in coma or death, the FDA said.
In the letters, the FDA requested responses from each of the companies within 10 working days. Companies failing correct the violations may be subject to legal enforcement action.