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March 22, 2016: FDA Opioid Warning Calls For Label Changes

FDA Opioid Warning

On March 22, 2016, the U.S. Food and Drug Administration (FDA) warned of dangerous interactions associated with all opioid pain medicines. Though opioids are powerfully effective in managing pain relief, these drugs also include many risks.

These risks include potential for harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. Keeping these in mind, the FDA has demanded a label change of all opioid drugs to warn of these risks.

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Attorney Eric H. Weinberg has played a significant role in multiple mass tort litigations against corporate pharmaceutical defendants. For a free drug lawsuit evaluation, please call us toll free at 1-877-934-6274, or submit the easy-to-use Free Legal Case Evaluation Form found on this page. Our phones are answered 24/7.
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The FDA Opioid Warning: The Risks Associated With Opioid Medications, and their Respective Label Changes After

The FDA addressed the potential danger posed by these drugs by supplementing the drugs’ labeling. The FDA opioid warning notice provided the following descriptions of the potential for harm, as well as their proposed label change:

Serotonin syndrome:

  • Opioids can interact with antidepressants and migraine medicines to cause a serious central nervous system reaction called serotonin syndrome, in which high levels of the chemical serotonin build up in the brain and cause toxicity (see List of Serotonergic Medicines).
    • The labels of all these drugs will be updated to include information about serotonin syndrome in the Drug Interactions and Adverse Reactions sections.

    Adrenal insufficiency:

  • Taking opioids may lead to a rare, but serious condition in which the adrenal glands do not produce adequate amounts of the hormone cortisol. Cortisol helps the body respond to stress.
    • We are requiring a new statement about adrenal insufficiency to be added to the Warnings and Precautions section of all opioid labels.

    Decreased sex hormone levels:

  • Long-term use of opioids may be associated with decreased sex hormone levels and symptoms such as reduced interest in sex, impotence, or infertility.
    • The labels of some opioids already describe this possible risk, and we are now adding consistent information to the Adverse Reactions section of all opioid labels.

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