FDA, Drug Makers Meet To Discuss Risk Management
The US Food and Drug Administration on Monday began a campaign to reduce the misuse of painkillers.
The FDA told the Associated Press that letters have been sent to companies that make opioid drugs that have dangerous effects when used inappropriately. These include like morphine, oxycodone and methadone.
Many of these drugs are used to treat patients of chronic pain, but they also can be highly addictive. Furthermore, the drugs are among the most highly abused for recreational purposes.
The agency has documented many cases of physicians prescribing the potent painkillers for patients with migraine headaches, an unapproved use.
The FDA said some patients will chew extended-release pills that are designed to be swallowed, causing an overdose of the drug.
"We’re focusing on these products because they generally contain very high doses of the drugs and need to be used very carefully," Jenkins said.
The FDA said it has issued warnings in recent years about the dangers of the drugs’ misuse.
"Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," said Dr. John Jenkins, FDA’s chief of new drugs. According to FDA, about 21 million prescriptions for opioids were dispensed in 2007.
FDA said it will meet with 16 drugmakers, including Johnson & Johnson (JNJ) (JNJ), King Pharmaceuticals and Purdue Pharma on March 3. Manufacturers of these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) “to ensure that the benefits of the drugs continue to outweigh the risks,” the FDA said in a statement.
“The FDA recognizes the need to achieve balance between appropriate access and risk mitigation, and believes an effective strategy would benefit from input from industry, patient advocacy groups, the pain and addiction treatment communities, the general public, and other stakeholders.”
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