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FDA Reviewing Narcotic Painkillers

Feb 10, 2009 | Parker Waichman LLP

The makers of two dozen opioid drugs, including Oxycontin, morphine, methadone and the Duragesic patch, have been ordered by the Food & Drug Administration (FDA) to develop Risk Evaluation and Mitigation Strategy (REMS) plans to reduce the misuse of their painkillers.  The FDA's latest action on these narcotic painkillers comes just days after the agency and the Centers for Disease Control (CDC) announced that they will be working together to look at the rising trend of accidental opioid overdoses.

According to an article on USNews.com, the FDA sent letters to 16 pharmaceutical companies that manufacture the two dozen narcotic painkillers that will be subject to the new review.  Drugs like the Duragesic fentanyl patch and Oxycontin are prescribed to treat chronic pain from cancer and other ailments.  According to the FDA, approximately 21 million prescriptions for 3.7 million patients were issued in 2007 for these medications.  A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.

In a press release, the FDA said that drug manufacturers have taken a number of steps in the past to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations, and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. The FDA said it  believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access.

The FDA has scheduled a meeting with drug makers for March 3.  After that meeting, the agency will work on putting new regulations in place for the painkillers.  USNews.com said the FDA expects the process to last for several months.  The new regulations could encompass additional warning labels, physician instructional materials, and stricter prescription indications, the report said.

Yesterday, we reported that the FDA and CDC had announced that they would be providing grants for research aimed at finding strategies to combat accidental painkiller overdoses.   According to the agencies, accidental overdose deaths from narcotics or hallucinogens in the 15-64 years age range rose 5,921 in 1999 to 10,829 in 2005, an 83 percent increase.  Unintentional overdoses not resulting in fatality saw a 44 percent increase from 376,611 to 542,372 accidents in the same time frame and within the same age group. Opioids painkillers were the prevailing factor in all the incidences.

According to the FDA, overdoses can occur if patients do not know how to take the drugs or if doctors drugs in a way that is not appropriate.  Other overdose deaths occur when legitimate prescriptions get into the hands of people other than the intended patient.


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