Beware of Companies Peddling Illegal Opioid Addiction Remedies

In the face of an ever-rising toll of opioid-related overdose deaths, some opioid-addicted patients in the U.S. and their loved ones are falling prey to unscrupulous companies hawking illegal, unapproved products purported to help in the treatment of opioid addiction and withdrawal. Fortunately, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) recently launched a crackdown against this latest health scam.[1]

On Jan. 11, the FDA and FTC sent joint warning letters to 11 marketers and distributors of opioid cessation products. The FDA cited the companies for illegally marketing unapproved drugs, while the FTC implied that they were making deceptive, unsubstantiated claims about the medications’ effectiveness.

All of the companies were using websites to make illegal health claims about their products, which were sold under brand names such as "Opiate Freedom 5-Pack," "TaperAid Complete," "Opiate Detox Pro" and "Withdrawal Support." Examples of claims made in the companies’ online promotional materials included:

• “#1 Selling Opiate Withdrawal Brand”
• “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal”
• “Break the pain killer habit”
• “Relieve Your Symptoms…addiction, withdrawal, cravings.”

In a Jan. 24 press release announcing the warning letters, the FDA noted that for patients struggling with opioid addiction, use of fraudulent, unapproved products based on deceptive claims about effectiveness may prevent them from seeking FDA-approved treatments that have been demonstrated to be safe and effective, thus delaying their path to recovery and putting them at greater risk of death.

FDA-approved drugs that have been shown to be safe and effective for use in medication-assisted treatment of opioid addiction or dependence include methadone (DOLOPHINE, METHADOSE), buprenorphine (PROBUPHINE, SUBLOCADE), buprenorphine-naloxone (BUNAVAIL, SUBOXONE, ZUBSOLV) and naltrexone (VIVITROL).[2] Methadone also has been approved by the FDA for opioid detoxification.[3]

These FDA-approved medications must be used in combination with counseling and behavioral therapies for treating substance abuse disorders. According to the Substance Abuse and Mental Health Services Administration, an agency within the U.S. Department of Health and Human Services, patients receiving FDA-approved medication-assisted treatment cut their risk of death in half.[4]

If you are exploring treatment options for opioid addiction for yourself or a loved one, don’t be conned by companies promising miracle cures. Instead, talk to your doctor about medication-assisted treatment using one of the FDA-approved drugs listed above.

References

[1] Food and Drug Administration. FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims. January 24, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm593602.htm. Accessed February 8, 2018.

[2] Substance Abuse and Mental Health Services Administration. Medication-Assisted Treatment (MAT). https://www.samhsa.gov/medication-assisted-treatment. Accessed February 9, 2018.

[3] West-Ward Pharmaceuticals. Drug label: methadone (DOLOPHINE). February 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006134s045lbl.pdf. Accessed February 9, 2018.

[4] Food and Drug Administration. FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims. January 24, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm593602.htm. Accessed February 8, 2018.