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FDA Announces new Label for Long Acting Opioid Class

Date: September 11, 2013
Source: FDA

On Sept. 10, 2013, the U.S. Food and Drug Administration announced a new class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain. Here are the salient points from the FDA press release and the relevant documents:

1. FDS is using its administrative authority to require safe labeling changes AND postmarket studies to "combat the crisis of misuse, abuse, addiction, overdose, and death" from these drugs.

2. The final version of the class-wide labeling changes will include important new language to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.

3. The INDICATION/LABEL CHANGES will state these words (or similar): Extended Release/Long Acting opioids 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.

4. The changes also clarify that "because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death," THESE DRUGS SHOULD BE RESERVED FOR USE IN PATIENTS FOR WHOME ALTERNATIVE TREATMENT OPTIONS (eg., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.

5. The FDA is also requiring the drug companies that make these products to conduct further studies and clinical trials. The purpose of this requirement is to "further assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death."

6. The FDA is also requiring a new boxed warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management according to protocols developed by neonatology experts. NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

7. There are other labeling changes that are more technical in nature and explained by the FDA material below. 

After labeling changes are finalized, the FDA-mandated ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), must be modified to reflect the updated information.

CRITICAL FDA MATERIALS

FDA GOALS OF LABELING CHANGES - IMPORTANT FOR PROVIDERS

FDA Letter to Manufacturers

Link to FDA Blog on Better Drug Labels

Link to Official Press Release on Topic

IMPORTANT: FDA Responses to the TWO CITIZEN PETITIONS CITED LISTED BELOW

FDA Response to PROP (physicians for responsible opioid prescribing)

FDA Response to Second Citizen Petition

 

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