August 28, 2018 — The U.S. Food and Drug Administration today announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.
“The illegal online sale of opioids represents a serious risk to Americans and is helping to fuel the opioid crisis. 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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”
Patients who buy prescription medicines, including opioids, from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. As noted in the warning letters, 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 illegal sale of these products is particularly concerning considering that FDA-approved tramadol carries a boxed warning, the FDA’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening adverse 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 networks receiving warning letters include:
The FDA requested responses from each of the companies within 10 working days. The companies are directed to inform the agency of the specific actions taken to address the agency’s concerns. Companies who fail to correct the violations, as outlined in the warning letters, may be subject to legal enforcement action.
Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. One critical step to addressing this public health emergency is the adoption of a more proactive approach by internet stakeholders to crack down on internet traffic in illicit drugs. Illegal online pharmacies, drug dealers, and others continue to use the internet to further their illicit distribution of opioids, where the risk of detection and repercussions is significantly reduced.
The FDA has been active in combating the illegal online sales of opioids. In June, the agency announced a similar series of warning letters, and on June 27 the FDA hosted internet stakeholders and thought-leaders, government entities, academic researchers, and advocacy groups at an Online Opioid Summit to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online. Topics that were addressed during the summit included: research into the ease with which illicit opioids can be purchased online and industry approaches to addressing opioids marketed online, followed by a roundtable discussion to identify gaps and new solutions. The FDA continues to be engaged with the companies that participated in the Summit and will share more in the coming months.
The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.
Posted: August 2018
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