FDA Fortifies Warning on Opioid Use Disorder

Buprenorphine, methadone and buprenorphine-naloxone are typically prescribed for the treatment of opioid use disorder .

The FDA is intensifying its warnings against the usage of opioids and benzodiazepines concurrently. This complete action is built on new information of three specific opioids— buprenorphine-naloxone, buprenorphine, and methadone, which are usually, prescribed for the cure of opioid use disorder—and the threat for respiratory depression when utilized with benzodiazepines or more central nervous system (CNS) depressants. Depending on the FDA Alert, “the joint usage of these drugs upsurges the risk of severe side effects; yet, the damage caused by untreated opioid addiction typically balances these risks. Cautious medication management by health care experts can reduce these hazards.”

Opioid Use DisorderThe FDA wants this information to be included in the methadone and buprenorphine drug labels laterally with thorough recommendations for reducing the usage of benzodiazepines and Medication Assisted Treatment (MAT) drugs jointly. This update trails earlier steps by the FDA to warn pharmacists, clinicians, and patients regarding the dangers of joining opioids with benzodiazepines.

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In the month of August 2016, the company called for a boxed warning to be included to the labels of all opioid painkillers, opioid-comprising cough products, and benzodiazepines. The cautioning defines the risks of taking opioids and benzodiazepines jointly, “which embrace respiratory depression, extreme sleepiness, coma and demise,” the agency stated.

This warning was an outcome of two studies that specified an increase in parallel opioid and benzodiazepine advising, along with a concurrent increase in the number of overdose demises concerning the two medication classes.

In a recent analysis led by Quest Diagnostics, an international drug testing company, above 20% of 33,000 samples tested for Opioid Use Disorder was positive for both benzodiazepines and opioids; above 10% were positive for both alcohol and opioids, and 3% were positive for all three elements.

FDA is recommending the health care experts to take numerous precautions and actions to develop a treatment plan when methadone or buprenorphine is used in a blend with benzodiazepines or other CNS suppressants. This embrace: including Opioid Use Disorder and death, Educating patients about the serious risks of combined usage that can occur with CNS suppressants.

Knowing that patients might require MAT medications indefinitely and their usage should endure for as long as patients are profiting. Harmonizing care to ensure other prescribers are aware of the patient’s methadone or buprenorphine treatment. Monitoring for illicit drug usage includes conducting blood or urine screening.

“Patients taking MAT drugs should continue to take these medications as suggested,” says FDA. “Stopping medications can cause other dangerous side effects. Patients are advised to talk with their chemists or clinician before starting new prescriptions.”