WASHINGTON, D.C. — The U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration have issued joint warning letters to four online networks, operating a total of 10 websites, illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol, that are potentially dangerous, the agencies announced Monday.
The warning letters issued to each of the networks state that they must immediately stop illegally selling these opioids to American consumers.
“As the FDA works to forcefully tackle the opioid crisis on all fronts, we cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said Acting FDA Commissioner Ned Sharpless, M.D. “Today’s effort is also noteworthy because while the FDA partners regularly with the DEA, this is the first time we have issued joint warning letters with them. This action further strengthens the warning to the operators of these websites. We remain committed to using all available regulatory and enforcement tools to stop the illicit flow of opioids online.”
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, the agencies say.
Additionally, several of these websites offer opioids online without a prescription, posing significant risks to patients. The FDA remains concerned that the easy availability of opioids online further fuels the crisis. 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 networks also violated the Controlled Substances Act (CSA) by failing to register their online pharmacies with the DEA despite knowingly or intentionally advertising the sale of controlled substances, including opioids. The CSA has, among other provisions, requirements that must be met for controlled substances (including opioids) to be legally distributed and dispensed via the internet. For example, an entity must be registered with the DEA to specifically dispense controlled substances; none are currently registered with the DEA to dispense or distribute controlled substances online.
“Issuing these warning letters is not only an effort to deter the availability of dangerous illegal opioids, but it is also a testament to the close cooperation between DEA and FDA,” said Acting DEA Administrator Uttam Dhillon. “We will continue to attack organizations that facilitate the sale of dangerous drugs, putting profit over public safety.”
The illegal sale of these opioids is particularly concerning because the FDA-approved tramadol carries a boxed warning, the agency’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening side 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 and DEA have requested responses from each of the companies within 15 working days. The companies are directed to inform each agency of the specific actions taken to address the violations noted in the warning letters. Companies that fail to correct the violations, as outlined in the warning letters, may be subject to legal enforcement action.
Source: U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration