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26-07-2012 | Article

Experts petition FDA to tighten opioid labeling

Abstract

Petition

MedWire News: A group of leading health experts and consumer health advocates is petitioning the Food and Drug Administration (FDA) to tighten opiate prescription labeling.

In an open letter to the FDA's Dockets Management Branch, a coalition of clinicians, researchers, and health officials say that for both instant- and extended-release opioids (eg, OxyContin), the current indications are too broad, and may lead to the false impression that opioids are safe and effective for long-term use for noncancer pain.

"Unfortunately, many clinicians are under the false impression that chronic opioid therapy (COT) is an evidence-based treatment for chronic noncancer pain (CNCP) and that dose-related toxicities can be avoided by slow upward titration. These misperceptions lead to over-prescribing and high dose prescribing.

"By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids. In addition, FDA will be able to reinforce adherence to dosing limits that have been recommended by the United States Centers for Disease Control, the state of Washington, and the New York City Department of Health and Mental Hygiene," write the members of Physicians for Responsible Opioid Prescribing.

Specifically, the group is asking the FDA to drop the word "moderate" from the approved indication of instant-release opioids for "moderate to severe pain." Additionally, it requests that the agency adds a maximum daily dose for noncancer pain equivalent to 100 mg of morphine, and a maximum duration of 90 days for continuous daily opioids for noncancer pain.

The petitioners note that "over the past decade, a four-fold increase in prescribing of opioid analgesics has been associated with a four-fold increase in opioid related overdose deaths and a six-fold increase in individuals seeking treatment for addiction to opioid analgesics."

They also report that a marketing campaign for OxyContin that "exaggerated benefits" of the drug and "minimized risks of long-term use for CNCP" resulted in an increase in opioid prescriptions over the past 15 years.

The petitioners - comprising experts in the fields of pain, addiction, primary care, internal medicine, anesthesiology, psychiatry, neurology, emergency medicine, toxicology, rheumatology, and public health - cite other studies noting that many patients with CNCP on opioids still experience significant pain and dysfunction while on the drugs, and that the drugs carry a high risk for dependence and addiction.

By Neil Osterweil