U.S: The U.S. Food and Drug Administration(USFDA) recently announced the issuance of two 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 they immediately cease offering violative drugs for sale to U.S. consumers.
The rise in illegal sales of opioids over the internet is a critical public health concern and main focus of attention by the FDA. These drugs are highly addictive and can be deadly when used without a doctor’s supervision, FDA officials said in a release.
According to the Centers for Disease Control and Prevention, in 2017, opioids killed 47,600 people in the U.S., a 13 per cent increase over the number killed in 2016.
Since 2017, the agency has issued 25 warning letters that identify more than 450 websites offering opioids for illegal sale.
FDA Commissioner Scott Gottlieb, M.D said, “Given the grave consequences of these illegal online sales, we’ve been aggressively targeting websites illegally offering opioids for sale. Today we added two more actions that now brings our total to 25 warning letters identifying more than 450 websites since September 2017.”
“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,” he added.
The sale of unapproved and misbranded opioids poses heightened dangers to consumers who purchase those products. 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 FDA’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 (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 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.