From USA Today:
The
Food and Drug Administration announced Monday that it was stepping up efforts to reduce unsafe use of 24
narcotics products — methadone pills, fentanyl patches and extended-release pills containing morphine, oxymorphone and oxycodone, such as OxyContin.
"This is a very extensively used group of medications," said John Jenkins, director of the FDA's Office of New Drugs. In 2007, he said, U.S. pharmacies dispensed 21 million prescriptions for the 24 opioid products, used by 3.7 million Americans.
Despite label warnings and collaborations between the FDA and other federal agencies, misuse, abuse and accidental overdoses of the products have grown over the past decade, he said. The FDA is concerned about doctors prescribing the drugs inappropriately, to patients who don't have moderate to severe chronic pain, Jenkins said. For example, "we continue to see case reports where someone with a sprained ankle receives a fetanyl patch or extended-release opioid," which, when chewed instead of swallowed whole, releases a large dose.
In addition, non-medical use by adults is rising. Data released Monday by the Substance Abuse & Mental Health Services Administration showed that non-medical use of prescription painkillers in Americans 18-25 rose from 4.1% in 2002 to 4.6% in 2007. Over that same period, non-medical use rose to 1.6% from 1.3% in Americans 26 and older.
The 16 companies that make the 24 products received FDA letters Friday saying their drugs must have a "Risk Evaluation and Mitigation Strategy," or REMS. A 2007 law authorized the agency to require REMS "to ensure that the benefits of the drugs continue to outweigh the risks," the FDA said. It will meet with the makers March 3 and with patient advocates and other stakeholders in late spring or early summer, Jenkins said.