FDA slams supplement company for selling unproven opioid withdrawal and migraine treatments
- FDA regulators sent a warning letter to EPH Technologies over three of its supplements
- One, Detoxoplex, is advertised for treating withdrawal symptoms
- Another two, Sinoplex and Migrenza are advertised for treating migraines and hangovers
- None of the products are approved for any of these uses, and the FDA called selling them under these claims a ‘potentially significant’ public health threat
The US Food and Drug Administration (FDA) has sent a warning letter to a company selling three unapproved drugs it’s advertised as opioid withdrawal treatments.
Regulators told EPH Technologies in a warning letter sent last week that it has 15 days to correct its marketing for three products: Detoxoplex, Sinoplex and Migrenza.
Its website advertises the latter two products for treating symptoms of several conditions, including migraines and hangovers.
EPH advertises Detoxoplex for treating opioid withdrawals, an unproven claim that regulators said ‘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 US Food and Drug Administration sent a warning letter to EPH Technologies warning the company it could face legal action if it doesn’t stop marketing its product, Detoxoplex (pictured), for the unproven purpose of treating withdrawal symptoms
Unlike withdrawals from most substances, opioid withdrawals can prove fatal in rare cases.
The intense symptoms that come on when someone who’s become opioid-dependent is without the drugs or effective addiction treatment medication include nausea and vomiting, anxiety, abdominal pain, tremors and irritability.
While withdrawal itself is not life-threatening, extreme dehydration from prolonged vomiting and diarrhea have the potential to be.
By 2016, an estimated 2.1 to 6 million Americans had opioid use disorders, meaning that many were dependent upon prescription or illicit opioids like OxyContin and heroin.
That year, at the height of the opioid epidemic, more than 70,000 people in the US overdosed on the drugs.
Addiction specialists widely agree that medication-assisted therapy (MAT) – a combination of behavioral therapy and drug treatment for withdrawal symptoms – is the best approach to treating use disorders.
FDA officials have approved three safe, effective MAT drugs: methadone, buprenorphine and naltrexone.
It’s possible but difficult to overdose on methadone and buprenorphine alone. Naltrexone is thought only to cause fatal overdoses if it’s combined with other substances, like heroin.
Because the risks associated with both opioids and drugs to treat opioid withdrawals are significant, the FDA tightly regulates both groups of drugs.
Detoxoplex is sold by EPH on Amazon as a ‘supplement’ and has not been approved by the FDA for treating opioid withdrawal.
Yet its Amazon page describes it as ‘withdrawal relief’ that ‘may assist in reducing withdrawal symptoms from decreasing or stopping the use of addictive substances.’
The warning letter slammed Detoxoplex as ‘misbranded,’ and asked EPH to correct its marketing or face legal action.
The company faces similar allegations over its other two products, Sinoplex and Migrenza, which the FDA says it has no grounds to sell as migraine and hangover treatments.
As of publication, EPH’s website did not provide contact for the company.
Sinoplex and Migrenza were still available on Amazon, but not EPH’s own site.
Detoxoplex was marked as ‘currently unavailable.’