The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.
Companies who fail to correct the violations, as outlined in the warning letters, may be subject to enforcement action, including product seizure or injunction.
“The FDA is taking additional steps to protect U.S. consumers from illicit opioids by targeting the websites that illegally market them and other illicit drugs. The internet is virtually awash in illegal narcotics and we’re going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales. As part of that effort, we’re hosting a summit with internet stakeholders to find new ways to work collaboratively with them to address these issues. At the same time, we’ll be taking action against firms whose websites deliberately break the law,” said FDA Commissioner Scott Gottlieb, M.D. “This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis. Today’s warning letters go right to the source of this illegal activity to let online network operators know that marketing illegal and unapproved opioids directly to U.S. consumers will not go unchallenged by the FDA. Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives. The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids. We’ll be following these actions with additional steps in coming months to crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail.”
Patients who buy prescription medicines 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 and oxycodone, in violation of the Federal Food, Drug, and Cosmetic Act.
This is particularly concerning considering that FDA-approved tramadol and oxycodone carry boxed warnings, which is the FDA’s most prominent warning, indicating that the drugs carry a significant risk of serious or even life-threatening adverse effects. The boxed warnings address 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, their use may result in coma or death.