A risk-management plan will be required to address the ongoing problems of misuse, abuse, inappropriate prescribing, and accidental overdoses of certain opioid medications, the Food and Drug Administration announced.
The agency said that letters had been sent to 16 manufacturers of 24 opioid products stating that a Risk Evaluation and Mitigation Strategy (REMS)—which is intended to address serious risks, including fatalities associated with the improper use of these drugs—will be required for their products. The FDA has addressed this problem in the past, with efforts that have included adding warnings to the product labels, direct communications to prescribers, and working with other federal agencies.
“Despite these efforts, the rates of misuse and abuse and of accidental overdosages of opiates have risen over the past decade,” Dr. John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said during a briefing. In 2007, 21 million prescriptions for these 24 products were dispensed to 3.7 million individual patients and were associated with “hundreds” of reports of deaths, he said.
Under legislation passed in 2007, the FDA can require a company to provide a REMS if the agency determines that such a plan is needed to ensure that the benefits of a drug outweigh its risks. The REMS may include a medication guide, provided to patients with each prescription filled; a patient package insert; and education of prescribers.
The opioid drugs on the FDA's list include fentanyl (Duragesic extended-release transdermal system), methadone (Dolophine tablets), oxycodone (OxyContin extended-release tablets), oxymorphone (Opana extended-release tablets), and several extended-release oral morphine products. These products are responsible for the greatest proportion of serious adverse events and deaths, according to Dr. Jenkins.
He emphasized that patients and physicians should follow the directions on the label. Although these products are intended only for people who experience moderate to severe pain, are opioid tolerant, and require around-the-clock pain relief, the FDA receives reports of adverse events in opioid-intolerant people who are inappropriately prescribed one of these products for conditions like a sprained ankle, he noted.
In an interview, Dr. Roy Altman, professor of rheumatology at the University of California, Los Angeles, noted that the majority of physicians tend not to use narcotics for chronic noncancer pain when indicated, because of legal ramifications, potential addiction risks, and other issues.
The agency will be holding several meetings to discuss the REMS plan for these products, and to obtain input from interested parties, including physicians, industry representatives, members of the pain- and addiction-treatment communities, and patient advocacy groups, beginning with a meeting on March 3 for manufacturers.
The full list of the drugs, along with the FDA's statement, is available at www.fda.gov/cder/drug/infopage/opioids/default.htmwww.fda.gov/MedWatch/report.htm