Opioid Abuse Targeted by the US FDA

Apr 21, 2011, 17:20 by Greg Stacy

Opioid abuse is being targeted by US health officials as they unveil a plan to reduce abuse of long-acting opioid pain killers.

This week the Food and Drug Administration announced the formation of the Risk Evaluation and Mitigation Strategy, part of the White House's larger multi-agency initiative aimed at curbing the misuse of prescription drugs in the US. REMS will focus on eliminating abuse of extended-release and long-acting opioid pain killers like OxyContin, morphine and methadone.

"This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain," Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, told Healthday.

For now the initiative will be dedicated to controlling extended-release and long-acting drugs. According to Woodcock, these drugs "have a much greater risk than immediate-release because they contain more medicine."

Woodcock didn't deny the possibility that in the future the initiative's focus could eventually be expanded to include immediate-release drugs. 

The action currently will affect 16 companies that are making branded and generic drugs. The drugs are known under their generic names as hydromorphone, methadone, morphine, oxycodone, oxymorphone, transdermal fentanyl and transdermal buprenorphine.

Woodcock says that every year approximately 23 million prescriptions are written for extended-release and long-acting opioids. Abuse of opioids is widespread in the US. The FDA estimates that 33 million Americans age 12 and older were using these drugs for non-medical purposes in 2007, up from 29 million people five years earlier. In 2006, 50,000 emergency room visits were reportedly related to opioids.

"This is a large and growing problem and, despite a number of efforts over the years, it continues to grow," Woodcock said. "It's clear we have a huge problem on our hands."

The new FDA program will educate prescribers on how to properly identify appropriate patients for these drugs.