Following new government figures showing a rise in nonmedical use of prescription painkillers among adults, the US Food and Drug Administration said Monday it will require manufacturers to impose stronger measures to curb misuse and abuse.
According to a survey released the same day by the Substance and Mental Health Services Administration, part of the Department of Health and Human Services, the number of adults aged 18 to 25 who reported using painkillers for nonmedical reasons increased from 4.1 percent in 2002 to 4.6 percent in 2007. The percentage was lower among adults ages 26 and older.
Furthermore, hundreds of patients die or are injured annually in the United States because inappropriate use of painkillers. Who is to blame for this situation? Apparently, doctors who prescribe poorly, patients who don’t take instructions seriously or get access to the drugs inappropriately and companies that have marketed their products illegally.
The FDA said that previous efforts to prevent abuse or misuse of painkillers such as adding warnings on products haven’t really worked.
“Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA believes that establishing a REMS [risk evaluation and mitigation strategy] for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access,” the regulatory agency wrote in a statement posted on its Web site.
The FDA has issued letters to 16 companies that make 24 opioid drugs, including morphine, oxycodone and methadone requiring their presence at a meeting scheduled on March 3 to discuss risk-management plans for the medications. The drugs had 21 million prescriptions written for them in 2007, to 3.7 million patients.
Companies required to attend the meeting include makers of generic pills as well as brand-name products, like Johnson & Johnson’s Duragesic, King Pharmaceuticals’ extended-releases Avinza pills and Purdue Pharma’s extended-release OxyContin.
These drugs are usually used by people already taking narcotics, such as cancer patients, to treat severe pain. However, these drugs can create addiction in a short period of time. Besides, they are often used for their euphoric effects.
The meeting could result in additional warning labels for the drugs, physician instructional materials and stricter prescription indications, the FDA said.
“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products. This is going to be a massive program,” Dr. John Jenkins, director of the FDA’s Office of New drug, part of the Center for Drug Evaluation and Research, said.
