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Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications

Audience: Family Practice, Psychiatry, Pain Management, Nursing, Endocrinology

ISSUE: FDA is warning about several safety issues with the entire class of opioid pain medicines. See the FDA Drug Safety Communication for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.

BACKGROUND: Opioids are powerful prescription medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief (see List of Opioid Medicines in the FDA Drug Safety Communication).  However, opioids also carry serious risks, including of misuse and abuse, addiction, overdose, and death.

Prescription opioids are divided into two main categories – immediate-release (IR) products, usually intended for use every 4 to 6 hours; and extended release/long acting (ER/LA) products, intended to be taken once or twice a day, depending on the individual product and patient.

See the FDA Drug Safety Communication for additional information, including a listing of opioids, serotonergic medicines, and a data summary.

RECOMMENDATIONS:

Serotonin syndrome:

Health care professionals should discontinue opioid treatment and/or use of the other medicine if serotonin syndrome is suspected.

Adrenal insufficiency:

Health care professionals should perform diagnostic testing if adrenal insufficiency is suspected. If diagnosed, treat with corticosteroids and wean the patient off of the opioid, if appropriate. If the opioid can be discontinued, follow-up assessment of adrenal function should be performed to determine if treatment with corticosteroids can be discontinued.

Decreased sex hormone levels:

Health care professionals should conduct laboratory evaluation in patients presenting with such signs or symptoms.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[03/22/2016 - Drug Safety Communication - FDA] 
[03/22/2016 - News Release - FDA]
 

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