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The FDA issues warnings for products marketed to treat opioid withdrawal

2019-11-28T20:11:07.140Z


The Food and Drug Administration (FDA) sent a warning letter to EPH Technologies, accusing it of marketing and selling unapproved medications.


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(CNN) - The Food and Drug Administration (FDA) sent a warning letter to EPH Technologies, accusing it of marketing and selling unapproved medications.

The products are sold under the names of Detoxoplex, Sinoplex and Migrenza, and are marketed for a number of conditions, including migraines and opioid withdrawal symptoms.

According to the EPH Technologies website, Detoxoplex can reduce the "symptoms typically associated with withdrawal of opioid use."

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In Tuesday's letter, the FDA said it has not been determined that the product is safe and effective for these uses.

"In addition, this unproven treatment could cause patients to give up or delay FDA-approved treatments for opioid addiction and withdrawal," he said. "The commercialization and sale of products not approved for the treatment of opioid addiction is a potentially important threat to public health."

Opioid withdrawal may include symptoms such as anxiety, nausea, vomiting and diarrhea. Typically, opioid withdrawal is managed with medically assisted treatments such as buprenorphine or methadone, along with behavioral therapy.

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Last May, the FDA approved Lucemyra, the first non-opioid medication to control opioid withdrawal symptoms. According to the Centers for Disease Control and Prevention of the United States, 2.1 million people in the United States had an opioid use disorder in 2016.

In addition to Detoxoplex, the FDA also cited two other unapproved medications from EPH Technologies: Sinoplex, which says it reduces “symptoms commonly associated with allergies, congestion, nausea, migraines, headache, hangover, colds, dizziness,” and Migrenza, which claims to relieve "headache, migraines, congestion and hangover."

EPH Technologies did not respond to requests for comments from CNN.

Opioid crisis

Source: cnnespanol

All news articles on 2019-11-28

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