FDA strengthens painkiller warning labels

WASHINGTON – The Food and Drug Administration is requiring stronger warning labels on prescription painkillers like OxyContin, in the government’s latest attempt to reduce overdose deaths caused by the long-acting medications.

The changes announced Tuesday are designed to remind doctors and patients about the fatal risks of misusing and abusing long-acting opioid pain relievers, which include forms of oxycodone, morphine and other narcotic medications. Whereas the previous label recommended the medications for “moderate to severe pain,” the new label describes a more limited role. It says the drugs should only be used for “pain severe enough to require daily, around-the-clock” treatment that cannot be managed with alternatives, such as over-the-counter medications or immediate-release opioids.

“These labeling changes describe more clearly the risks and safety concerns associated with ‘extended release and long-acting’ opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs,” the FDA’s Dr. Douglas Throckmorton said in a statement.

The new label also includes a boxed warning about the risks of opioid withdrawal syndrome in infants who are exposed to the drugs during pregnancy, labor and nursing.

The FDA is also requiring manufacturers of the targeted products to conduct long-term studies tracking rates of misuses, abuse, addiction and death among patients.

Tuesday’s action affects about 20 prescription products, including Purdue Pharma’s OxyContin, Johnson & Johnson’s Duragesic patch and Pfizer’s Embeda.

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