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FDA Warns Against Unapproved Drugs For Opioid Withdrawal

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The U.S. Food and Drug Administration or FDA has issued a warning letter to EPH Technologies for sale of unapproved drugs including that for opioid withdrawal.

According to the health regulator, various EPH products, including Detoxoplex, Sinoplex and Migrenza, are unapproved new drugs sold in violation of Federal Food, Drug, and Cosmetic Act. These are marketed for a number of conditions, including migraines and opioid withdrawal symptoms.

FDA accused that EPH market "Detoxoplex" for the treatment or cure of opioid withdrawal symptoms, but it has not been determined by FDA to be safe and effective for these uses.

The FDA said, "Further, this unproven treatment could cause patients to forgo or delay FDA-approved treatments for opioid addiction and withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health."

The agency also warned against EPH's Sinoplex, which claims to reduce symptoms commonly associated with allergies, and migraines, and Migrenza, which claims to relieve headache, migraines, congestion and hangover.

The agency had earlier approved Lucemyra, the first non-opioid drug to manage opioid withdrawal symptoms.

The opioid crisis in the U.S. is growing at an alarming rate. According to the U.S. Centers for Disease Control and Prevention, Opioid addiction claimed about 400,000 lives in the United States from 1999 to 2017, of which around 47,600 overdose deaths in 2017 alone.

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