FDA seeks plans to reduce misuse of painkillers

WASHINGTON – Federal health regulators 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 Monday it has issued letters to companies that make opioid drugs, including morphine, oxycodone and methadone.

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 the drugs in recent years and some companies already have plans to manage the drug's risks.

"Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," said Dr. John Jenkins, FDA's chief of new drugs. According to FDA, about 21 million prescriptions for opioids were dispensed in 2007.

FDA said it will meet with 16 drugmakers March 3 to discuss risk-management plans for the medications. Such plans can include bolstered warning labeling, restrictions on patients who can receive the drugs and cautionary letters to physicians.

Companies asked to attend include makers of generic pills as well as brand-name products, like those from Johnson & Johnson, King Pharmaceuticals and Purdue Pharma.

Regulators said continuing deaths from the drugs are due to both abuse by patients and inappropriate prescribing by physicians. The agency has documented many cases of physicians prescribing the potent painkillers for patients with migraine headaches, an unapproved use. The FDA said patients will also sometimes chew extended-release pills that are designed to be swallowed, causing an overdose of the drug.

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

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