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FDA Fortifies Warning on Opioid Use Disorder

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

Opioid-Use-Disorder

The FDA is intensifying its warnings against the use 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 healthcare experts can reduce these hazards.”

The FDA wants this information to be included on 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 on 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.

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