FDA issues warning for products marketed to treat opioid withdrawal
Posted November 28, 2019 8:29 a.m. EST
CNN — The FDA sent a warning letter to EPH Technologies, accusing it of marketing and selling unapproved drugs.
The products are sold under the names Detoxoplex, Sinoplex and Migrenza, and are marketed for a number of conditions, including migraines and opioid withdrawal symptoms.
According to EPH Technologies' website, Detoxoplex can reduce "symptoms typically associated with withdrawal from opioid use."
In Tuesday's letter, the FDA said the product has not been determined to be safe and effective for these uses. "Further, this unproven treatment could cause patients to forgo or delay FDA-approved treatments for opioid addiction and withdrawal," it said. "The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health."
Opioid withdrawal can include symptoms such as anxiety, nausea, vomiting and diarrhea. Typically, opioid withdrawal is managed with medically assisted treatments such as buprenorphine or methadone, in conjunction with behavioral therapy. Last May, the FDA approved Lucemyra, the first non-opioid drug to manage opioid withdrawal symptoms. According to the US Centers for Disease Control and Prevention, 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 drugs 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 CNN's requests for comment.