Tuesday, February 17, 2009

FDA seeks to reduce misuse of painkillers

WASHINGTON - Federal health regulators in the United States are requiring more than a dozen drugmakers to develop plans to reduce the misuse of their painkillers, which cause hundreds of deaths each year.

The Food and Drug Administration said this week it has issued letters to companies that make 24 opioid drugs, including morphine, oxycodone and methadone. Opioids are drugs that simulate the effects of natural opiates, such as opium poppy.

The products targeted by FDA, which come in both pill and patch forms, generally feature extended-release formulas designed to give long-lasting effects. But regulators warned that potency carries serious risks.

"We're focusing on these products because they generally contain very high doses of the drugs and need to be used very carefully," said Dr. John Jenkins, FDA's chief of new drugs.

The drugs are typically used by people already taking narcotics, such as cancer patients, to treat severe flare-ups of pain. Despite their ability to relieve chronic pain the drugs can be highly addictive and are often abused for their euphoric effects.

The FDA has issued a number of warnings on prescription pain relievers in recent years and some companies already have plans to manage the drugs' risks.

"Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," said Jenkins.

According to FDA, about 3.7 million patients were taking the drugs under scrutiny in 2007. A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.

FDA said it will meet with 16 drugmakers March 3 to discuss risk-management plans for the medications.

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