In first-ever joint warnings, the FDA and DEA have sent letters to four online networks that operate 10 individual websites that market “unapproved and misbranded versions of opioid medicines, including tramadol, that are potentially dangerous. ”
“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.
The FDA notes that some of the medications, such as tramadol, carry a black box warning because of a significant risk of serious or even life-threatening side effects.
The press release notes the U.S. Department of Justice’s Narcotic and Dangerous Drug Section attorneys assigned to the DEA’s Special Operations Division and Policy Unit assisted in drafting the warning letters sent to the website operators.
The warnings signify new inter-agency joint efforts to investigate and pursue unregistered online pharmacies under the Controlled Substances Act (CSA).
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