Makers of Powerful Painkillers Present Safety Plans
FRIDAY, Dec. 4 -- The makers of 24 different prescription painkillers on Friday presented federal regulators with plans to curb the abuse of these opioid drugs.
The pharmaceutical companies have been under pressure from U.S. Food and Drug Administration officials to find a way to stop the hundreds of fatal overdoses that occur with these medications each year, the Associated Press reported.
Executives from Johnson & Johnson, King Pharmaceuticals and other drug makers proposed using patient medication guides, letters to doctors and additional physician training to end the misuse and inappropriate prescribing of painkillers, according to the wire service.
In February, FDA officials sent letters to 16 companies ordering them to design risk-management plans for their drugs. The drug makers presented their joint proposal to the agency after several months of discussion.
The painkillers in question include morphine, oxycodone and methadone.
This marks the first time the agency has required a risk-management plan for an entire class of drugs, the AP reported.
However, the problem is significant: a 2007 survey found 5.2 million people in the United States reported using prescription painkillers inappropriately.
Such drugs are typically approved for people requiring round-the-clock treatment for moderate to severe chronic pain, such as cancer patients.
But, significant harm can occur if patients are uninformed about how to properly take the drugs, doctors inappropriately prescribe the drugs, or if legitimate prescriptions get into the hands of people other than the intended patient, Dr. John Jenkins, director of the FDA's Office of New Drugs, part of the Center for Drug Evaluation and Research, said during a news conference back in February.
Jenkins said then that the agency was taking this step to implement "a relatively massive new program," because "the rates of misuse and abuse [of opiates] have risen over the past decade." He also said the FDA was better able to address the problem, because the Food and Drug Administration Amendments Act of 2007 gave the agency the authority to regulate opioids.
This is "our attempt to try and ensure that the benefits of the products outweigh their risks," Jenkins said in February.
In addition to patient misuse, the FDA has documented many cases of physicians prescribing the potent painkillers for people with migraines, an unapproved use. The FDA said patients also sometimes chew extended-release pills that are designed to be swallowed, causing an accidental overdose of the drug.
Posted: December 2009