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1 October 2019Big PharmaSaman Javed

FDA and DEA warn over sale of misbranded opioid drugs

The US Food and Drug Administration ( FDA) and Drug Enforcement Administration ( DEA) have issued joint warning letters to four online networks which allegedly sell unapproved and misbranded versions of medicines.

In an announcement yesterday, September 30, the FDA and DEA said the networks operated a total of ten websites selling counterfeit opioid medicines.

The four networks are Divyata, Euphoria Healthcare, JCM Dropship and Meds4U.

In their warnings, the FDA and DEA ordered the networks to immediately cease the sale of the opioids, including tramadol, a strong painkiller.

The administrations said they were particularly concerned about the sale of counterfeit tramadol because it didn’t carry the FDA’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening side effects.

When taken with other central nervous system depressants, including alcohol, tramadol’s use may result in coma or death.

According to the release, the letters are the latest demonstration of the government’s commitment to stopping the country’s widespread opioid addiction, which is an “immense public health crisis”.

Acting FDA commissioner, Ned Sharpless, said it was the first time the administration had sent joint warning letters with the DEA.

“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,” Sharpless said.

Acting DEA administrator Uttam Dhillon said: “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.”

The FDA also warned consumers against buying prescription medicines from illegal online pharmacies because the products are often counterfeit, contaminated, expired or otherwise unsafe.

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30 August 2018   The US Food and Drug Administration has warned 21 websites over the illegal marketing of misbranded versions of opioid medications.

More on this story

Americas
30 August 2018   The US Food and Drug Administration has warned 21 websites over the illegal marketing of misbranded versions of opioid medications.