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FDA Strengthens Pain Drugs’ Warnings

Goal is better prescribing, safer use of opioids (September 10)

Health care professionals and consumers will soon find updated labeling for extended-release and long-acting (ER/LA) opioid pain relievers to help ensure their safe and appropriate use.

In addition to requiring new labeling on these prescription medications, the FDA is requiring manufacturers to study certain known serious risks when these drugs are used long-term.

ER/LA opioids pose a particular safety concern because they produce their effects for a longer period, and many contain higher doses compared with immediate-release or opioid/nonopioid combination products. They include long-acting versions of morphine, oxycodone, and fentanyl.

Currently, labeling on ER/LA opioids indicate that they are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.” However, the updated indication for when to prescribe and take these medicines will, when finalized, emphasize that other, less potentially addictive, treatment options should be considered first.

The FDA is requiring labeling that says the drugs are “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

The “limitations of use” portion of the new labeling retains language indicating that the drugs are not intended for use as “as-needed” pain relievers. Furthermore, the new labeling adds: “Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

Source: FDA; September 10, 2013.

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