FDA strengthens painkiller warnings to clarify risks as overdoses, abuse surge
WASHINGTON — The Food and Drug Administration is requiring stronger warning labels on prescription painkillers such as OxyContin, in the government’s latest attempt to reduce overdose deaths caused by the long-acting medications.
The changes announced on 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,” said Dr. Douglas Throckmorton of the FDA.
The label includes a boxed warning about the risks of opioid withdrawal syndrome in infants who are exposed to the drugs during pregnancy, labor and nursing. Symptoms may include rapid breathing, trembling and poor feeding habits.
The FDA is requiring manufacturers of the targeted products to conduct long-term studies tracking rates of misuse, abuse, addiction and death among patients.
The action affects about 20 prescription products, including Purdue Pharma’s OxyContin, Johnson & Johnson’s Duragesic patch and Pfizer’s Embeda. Opioids are drugs that simulate the effects of natural narcotics, such as the opium poppy. They are typically prescribed for people taking pain medications, including cancer patients, to treat severe pain flare-ups.
The FDA has issued a number of warnings about the dangers of prescription pain relievers in recent years, but with little effect. Inappropriate use of opioids caused more than 16,650 overdose deaths in 2010, up more than 12 percent from 2008, according to the Centers for Disease Control and Prevention.