The Food and Drug Administration is modifying safety labeling and postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics for the treatment of pain.


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FDA to change safety labeling for opioid analgesics

September 11th, 2013

WASHINGTON – The Food and Drug Administration is modifying safety labeling and postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics for the treatment of pain.

The FDA said Tuesday that the labeling changes, which take into greater account the risks of using these drugs, will include new language to help health care professionals tailor their prescribing decisions based on a patient's individual needs.

"The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities," FDA Commissioner Margaret Hamburg said in a statement. "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."

The updated indication states that ER/LA opioids are indicated for the management of pain that's severe enough to call for around-the-clock, long-term opioid treatment and for which other treatment options are insufficient.

In addition, the new indication emphasizes that because of the risks of addiction, abuse, and misuse — even at the recommended doses — and because of the risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (such as non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated or would be inadequate to provide sufficient management of pain. ER/LA opioid analgesics aren't indicated for as-needed pain relief.

"The FDA's primary tool for informing prescribers about the approved uses of medications is the product labeling," explained Douglas Throckmorton, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate prescribing, monitoring and patient counseling practices involving these drugs."

Given the need for more information on the risks from long-term use of ER/LA opioids, the FDA also is requiring the drug companies that make these products to conduct further studies and clinical trials. Specifically, the new postmarket requirements aim to further assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose and death.

A new boxed warning on ER/LA opioid analgesics also is now being required to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can occur in a newborn exposed to opioids while in the mother's womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

In addition, the FDA is notifying ER/LA opioid analgesic application holders of the need for changes to the following sections of drug labeling: dosage and administration, warnings and precautions, drug interactions, use in specific populations, patient counseling information and the medication guide.

The agency added that once the safety labeling changes are finalized, modifications will also be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) to reflect the updated information.

Approved in 2012, the ER/LA Opioid Analgesics REMS requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide medication guides and patient counseling documents containing information on the safe use, storage and disposal of these drugs.

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