Websites Offering Sale of Opioids are Targets of FDA Warning Letters

Officials with the FDA announced today the issuance of 2 warning letters, to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications, including tramadol. The warning letters issued to azmedicinalshop.com and thedonrx.net request that these enterprises immediately cease offering violative drugs for sale to consumers in the United States.

The rise in illegal sales of opioids over the Internet is a critical public health concern and major focus of attention by the FDA, according to the agency. These drugs are highly addictive and can be deadly when used without a doctor’s supervision, FDA officials said, in a press release.

Since September 2017, the agency has issued 25 warning letters that identify more than 450 websites offering opioids for illegal sale.

“Given the grave consequences of these illegal online sales, we’ve been aggressively targeting websites illegally offering opioids for sale,” said FDA Commissioner Scott Gottlieb, MD. “While we’ll continue to identify and take action against violative websites, we know that enforcement action alone is unlikely to stop new websites from starting up. Stopping these websites from illegally offering opioids for sale will require a broad collaboration across the internet community.”

According to the Centers for Disease Control and Prevention, in 2017, opioids killed 47,600 people in the U.S., a 13 percent increase over the number killed in 2016. Addressing this crisis is one of the FDA’s highest priorities, and the agency’s efforts support the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis, Gottlieb said.

The sale of unapproved and misbranded opioids poses heightened dangers to consumers who purchase those products, FDA officials said. Patients who buy prescription drugs, including opioids, from illegal online pharmacies may put 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 to sell 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.

While the agency is concerned about online sales of all the opioid products, the warning letters issued to azmedicinalshop.com and thedonrx.net specifically cite the illegal sale of tramadol. As with all opioids, FDA-approved tramadol has a boxed warning, the agency’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning also addresses risks including addiction, abuse, misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. In addition, when taken with other central nervous system depressants, including alcohol, tramadol’s use may result in coma or death.

The FDA requested responses from each of the warning letter recipients within 15 working days. They are directed to inform the agency of the specific actions taken to address the violations outlined in the warning letter. Those entities that fail to correct the violations may be subject to further regulatory action.

Reference

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids [news release]. Silver Spring, MD; April 2, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635018.htm. Accessed April 2, 2019.