Thursday, September 19, 2013

Opioid Label Change

According to an article published in MedPage Today, the FDA has ordered a class-wide label change for long-acting opioids. The opioids, such as OxyContin, would be limited to patients with only severe pain.

With this move, the agency hopes it will help the prescription painkiller epidemic. The drugs, which are important pain relieving medications that provide significant benefits when used appropriately, will also include a label clarification about the risks of abuse and death while taking it as well as a boxed warning about the risks of neonatal opioid withdrawals syndrome.

The indication of the drugs will be changed to people who have pain severe enough to require daily and long-term treatment where alternative treatment options are inadequate. Physicians and patients will have to discuss the eligibility of the opioids. Therefore, patients in pain will be assessed by a thoughtful determination of pain instead of by a rating on a pain scale. 

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