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FDA Stipulates Safety Label Update for Opioid Analgesics

Further clinical trials, too, required of extended-release, long-acting drugs

FDA Stipulates Safety Label Update for Opioid Analgesics

TUESDAY, Sept. 10 (HealthDay News) -- In an attempt to reduce the risks of misuse, abuse, addiction, and other complications associated with extended-release and long-acting (ER/LA) opioid pain relievers, the U.S. Food and Drug Administration is requiring changes to safety labeling as well as post-market studies of the drugs.

The labeling changes are intended to better guide health care professionals in tailoring the prescription of such analgesic medications to their patient's specific needs. For instance, the labeling changes will clarify that ER/LA opioids are not indicated for use on an as-needed basis, but for patients with chronic, severe pain for whom alternatives are ineffective.

The FDA is also requiring further studies and clinical trials of ER/LA opioid analgesics in order to better assess the already known risks associated with their use, such as hyperalgesia, overdose, and death.

"Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended-release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain," Margaret A. Hamburg, M.D., Commissioner of the FDA, said in a statement.

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