FDA seeks review of opioid drugs for reducing associated risks

In its letters addressed to 16 pharmaceutical companies, the Food and Drug Administration (FDA) has asked the opioid drug-makers to formulate a plan for reducing risks associated with 24 opioid drugs being manufactured - including morphine, oxycodone and methadone.

Opioids essentially are those drugs that reproduce the effects of natural opiates, such as opium poppy, and come in both pill and patch forms. These painkillers are extended-release formulas, which give long-lasting effects. However, regulators have expressed concern over the fact that the potency of these drugs can be a source of grave risks.

FDA officials said that with these drugs to be subject to the new appraisal, the move could result in other warning labels, practitioner instructional materials, and more stringent prescription suggestions.

Calling the latest endeavor - resulting from the FDA Amendments Act of 2007 - a multi-point and multifaceted program, Dr. John Jenkins, director of the FDA's Office of New Drugs, said the effort would check "the rates of misuse and abuse of opiates that have risen over the past decade."

Speaking at a teleconference on Monday, Jenkins said that in 2007, 3.7 million patients were issued prescriptions for the targeted medications. He added that though use of opioid drugs is characteristically permitted for patients with moderate to severe chronic pain, such as in the case of cancer patients, there underlying risk cannot be overlooked! (Harkiran Contributed to this report)

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