March 22, 2016
2 min read
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FDA issues new warnings for opioid medications

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The FDA is requiring a boxed warning about the risks of opioid abuse, misuse, overdose, addiction and death for immediate-release opioid pain medication, according to a press release.

The FDA is also requiring labeling changes for all prescription opioid products that will detail risks.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” Robert Califf, MD, FDA commissioner, said in the release. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

Robert Califf

Robert Califf

Immediate-release opioids should only be used "for pain severe enough to require opioid treatment and for which alternative treatment options (eg, nonopioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated," according to the FDA. Dosing instructions also include clearer information on how to monitor patients and administer opioids.

The FDA is also requiring a precaution on chronic opioid use during pregnancy, which can result in neonatal opioid withdrawal syndrome (NOWS) as part of the boxed warning on immediate-release opioids.

“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with [immediate-release] opioid products,” Douglas Throckmorton, MD, deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research, said in the release. “Today, we have taken an important next step in clarifying and making more prominent the known risks of [immediate-release] opioid medications.”

The FDA is also requiring label changes to all opioid drugs regarding interactions with other medications, decreased levels of sex hormones and adrenal gland issues.

According to the agency, opioids can interact with antidepressants and migraine medications and can cause serotonin syndrome, a serious central nervous system reaction. This syndrome can manifest with symptoms that include hallucinations, rapid heart rate, agitation, excessive sweating and muscle twitching. Health care providers are advised to stop opioid treatment and/or the other medication if serotonin syndrome is suspected.

Long-term opioid use may be associated with decreased sex hormone levels, and symptoms such as impotence, reduced interest in sex or fertility. Health care providers should conduct a laboratory evaluation to confirm hormone levels if a patient presents with associated symptoms.

Opioid use may also lead to adrenal insufficiency, which keeps the adrenal glands from producing enough cortisol. Symptoms include nausea, vomiting, fatigue and weakness. Health care providers are advised to perform diagnostic testing if they suspect adrenal insufficiency. If adrenal insufficiency is diagnosed, providers should wean patients off of opioids and appropriately treat patients with corticosteroids.

“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”