FDA orders more instruction on use of painkillers

By Reuters
Posted yesterday at 12:29 p.m.

The U.S. health regulator ordered painkiller makers to provide educational materials to help train physicians about the correct use of the drugs, as part of the Obama administration’s plan to tackle prescription drug abuse.

The  Food and Drug Administration has sent letters to makers of  opioids, asking them to prepare materials that physicians or prescribers can use while counseling patients about the risks and benefits of the drugs.

While the documents will be prepared by the drugmakers, the FDA will approve them, commissioner Margaret Hamburg said at a news conference Tuesday.

Drugs that require the new educational guidelines include Johnson & Johnson’s Duragesic, Pfizer Inc. unit King Pharma’s Avinza and Embeda, Actavis’ Kadian and Endo Pharmaceuticals’ Opana ER.

The list also includes some generic opioids made by Mylan, Teva Pharmaceutical Industries, Watson Pharmaceuticals, Novartis unit Sandoz, KV Pharmaceuticals and Impax Laboratories.

Opioids are synthetic versions of opium used to treat moderate and severe pain.

Prescription drug abuse has become a serious concern and was the second-biggest reason behind accidental deaths in 2007.

The drugmakers have 120 days to propose a plan for their drugs. FDA will be getting back to drugmakers within 120 days of the plan submission.

Doctor training, patient counseling and other risk reduction measures developed by opioid makers as part of the plans, known as risk evaluation and mitigation strategies, are expected to take effect by early 2012.

“The prescriber education component of the opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks,” Hamburg said.

The plans aim to make sure specific drugs are used only for the purposes they were approved for and not anything else, thus cutting down misuse without restricting access.

FDA estimates that more than 33 million Americans 12 and older misused extended-release and long-acting opioids during 2007, up from 29 million just five years earlier.

“This is a problem that touches all of us,” FDA commissioner Hamburg said.

According to Centers for Disease Control and Prevention data, opioid overdose killed far more people than overdose of street drugs such as cocaine and heroin.

However, the actions are not expected to put a new burden on the health care system, Gil Kerlikowske, director of the White House Office of National Drug Control Policy, told reporters.

“There is very little money involvement,” Kerlikowske said.

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