Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA Drug Safety Podcasts

FDA Drug Safety Podcasts Home
          Drugs
          Drug Safety and Availability
          FDA Drug Safety Podcasts
          FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changesFDA Drug Safety Podcasts FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes
  
  	
    Share
    Post
    Linkedin

    Email
    PrintListen

Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.

On March 22, 2016, FDA announced warnings about several safety issues with the entire class of opioid pain medicines. 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.

Opioids can interact with antidepressants and migraine medicines to cause a serious reaction called serotonin syndrome.
	Taking opioids may lead to a rare, but serious condition in which the adrenal glands do not produce adequate amounts of cortisol.
	Long-term use of opioids may be associated with decreased sex hormone levels and symptoms such as reduced interest in sex, impotence, or infertility.Opioids are used to treat moderate to severe pain that may not respond well to other pain medicines. Opioids also have serious risks including misuse and abuse, addiction, overdose, and death.

Health care professionals should discontinue opioid treatment and/or use of the other medicine if serotonin syndrome is suspected. Serotonin syndrome cases were reported more frequently in the FDA Adverse Event Reporting System (FAERS) database with fentanyl and methadone used at recommended doses. We are requiring a new statement be added to these drug labels. Some opioids already have serotonin syndrome warnings. Cases were also reported with other opioids and these drug labels will be updated.

Health care professionals should perform diagnostic testing if adrenal insufficiency is suspected. If diagnosed, treat with corticosteroids and wean the patient off the opioid, if appropriate. If the opioid can be discontinued, follow-up assessment of adrenal function should be performed to determine if corticosteroid treatment can be discontinued. We are requiring a new statement about adrenal insufficiency be added to all opioid labels.

Health care professionals****should conduct laboratory evaluation in patients presenting with signs or symptoms of decreased sex hormone levels. We reviewed published studies assessing levels of sex hormones in patients taking opioids chronically. All had limitations making it difficult to determine if symptoms were caused by opioids or other factors. Some opioid drug labels already describe this possible risk. Consistent information will be added to all opioid labels.

Side effects involving opioids should be reported to FDA’s MedWatch program at: www.fda.gov/medwatch.

A link to the full communication detailing information for health care professionals and the data summary can be found at www.fda.gov/drugsafetycommunications. Thank you for listening.

Related Information

FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes
	FDA Drug Safety Podcast: FDA warns about several safety issues with opioid pain medicines; requires label changes

                                                                                  Content current as of:
      01/19/2022FDA Drug Safety Podcasts
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop