FDA Steps Up Efforts to Control Painkiller Use

February 10, 2009 05:24 PM
by Cara McDonough
The FDA is launching a campaign against unsafe use of certain narcotics, pointing to a growing misuse of painkillers over the past decade.

Assessing the Risks

Drugs with ingredients including fentanyl, hydromorphone, methadone, morphine, oxycodone and oxymorphone will undergo tests ensuring that their benefits outweigh their risks, according to a statement on the U.S. Food and Drug Administration Web site.

What does that mean for consumers? That the opioid-type painkillers prescribed to 3.7 million Americans may soon be harder to get.

Misuse of the products, including accidental overdoses, has grown significantly in the past 10 years, explained John Jenkins, director of the FDA’s Office of New Drugs, to USA Today.

He said that the agency is most concerned about the incidence of doctors prescribing the drugs, which include brand-name medications like Vicodin and OxyContin, to patients who don’t really need them. For example, he said they see cases where doctors prescribe a fetanyl patch or extended-release opioid to someone with a sprained ankle, which “when chewed instead of swallowed whole, releases a large dose,” according to the story.

Nonmedical use of these painkillers is also growing at an alarming rate. The Substance Abuse & Mental Health Services Administration released data this week showing that nonmedical use of prescription painkillers in Americans ages 18–25 years old rose from 4.1 percent in 2002 to 4.6 percent in 2007.

The FDA plans to study 24 drugs made by 16 companies using a “Risk Evaluation and Mitigation Strategy,” or REMS. The specific evaluation is required by a 2007 law enacted to ensure that the benefits of these medications outweigh their risks.

Background: The pros and cons of painkillers

Although the painkillers included in the FDA study may get a bad reputation due to misuse and over prescription, the drugs do help restore quality of life to those with chronic and incurable pain, as explored in a New York Times article on the drug methadone. 

Still, risks—including the risk of death—persist.

“This is a wonderful medicine used appropriately, but an unforgiving medicine used inappropriately,” Dr. Howard A. Heit, a pain specialist at Georgetown University, told The New York Times. According to the story, between 1999 and 2005, deaths that listed methadone as a contributor increased nearly fivefold, to 4,462.

The drug, once used in addiction centers to treat heroin withdrawal, is now used very successfully to abate pain for those suffering from certain conditions. Alexandra Sherman lived with debilitating hip and shoulder pain for years, but a methadone prescription “has given me my life back,” she said in the Times piece.

But it’s not only potent prescription drugs like methadone and OxyContin that are the problem, say some doctors. In 2006, the FDA announced it would call for stronger warning labels on certain over-the-counter drugs.

"Acetaminophen is a very dangerous drug," Dr. John Brems, professor of surgery and chief of intra-abdominal transplantation at Loyola University, told ABC News at the time. He said he sees at least a dozen patients a year that suffer liver failure related to the drug. Liver complications related to the combination of acetaminophen with alcohol are one of the noted risks.

Despite the undeniable dangers associated with painkillers, the drugs are useful when needed and the trick may be in finding the right balance. Many experts agree chronic pain must be treated effectively for positive quality of life. Case in point: A study released in November 2008 suggested that for people suffering from chronic pain, the risk of suicide may be higher.

Reference: Prescription drugs; drug misuse


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