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FDA acts on painkiller risk.

WASHINGTON -- The Food and Drug Administration has taken several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene. The steps were taken because of data linking propoxyphene and fatal overdoses.

The agency wants manufacturers of products that contain propoxyphene (including Darvon and Darvocet) to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. They will also be required to provide to patients a medication guide stressing the importance of using the drugs as directed. In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher-than-recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action.

"Physicians need to be aware of the risk of overdose when prescribing these drugs, and they should carefully review patient histories and make appropriate treatment decisions based on the warnings and directions stated within the drug's label," comments Janet Woodcock, who serves as director of the FDA's center for drug evaluation and research. "Prescribers and patients should be aware of propoxyphene's potential risks when used at doses higher than those recommended.

"The FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy."

Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA or to provide a reason why they do not believe such changes are necessary.

Separately, the FDA denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene. The agency said that despite the FDA's serious concerns about propoxyphene, the benefits of using the medication for pain relief at recommended doses outweigh the safety risks at this time.

The formal FDA action regarding propoxyphene came just days after an agency advisory panel voted to recommend a ban on Percocet and Vicodin, two other popular painkillers, because of their effects on the liver. The two prescription products combine a narcotic with acetaminophen, the ingredient found in such popular over-the-counter products as Tylenol and Excedrin. But the panel rejected a proposal to take the nonprescription items off store shelves.

Among those reacting to that recommendation was Linda Suydam, president of the Consumer Healthcare Products Association (CHPA).

"CHPA strongly believes patients and physicians should continue to have access to the current range of over-the-counter acetaminophen-containing products, and we are pleased the committee did not recommend eliminating these important nonprescription products," says Suydam. "While we are pleased with the committee's recommendation to allow continued access to O-T-C combination medicines containing acetaminophen because we know they provide real benefits to consumers, we are disappointed in their divided vote to lower the maximum daily dose and the single dose of 1,000-mg acetaminophen.

"There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms."


There is universal agreement on the safety of acetaminophen when used as directed on the label, Suydam stresses. "We know the overwhelming majority of adults use this product safely and that the majority of serious adverse events related to unintentional acetaminophen overdose are associated with prescription medicines containing acetaminophen," she says.

Besides the label, the most effective and appropriate intervention to address overdose is education," Suydam maintains. "We support educational efforts to encourage appropriate use of acetaminophen and have already begun developing a comprehensive research-based education program that includes a consortium of pharmacists, physicians, retailers, FDA and other health care professionals," she points out.

Suydam says CHPA urges the regulatory agency to add acetaminophen dosing instructions on pediatric products intended for children (6 months to under 2 years of age).

"All of our companies provide dosing instruments with their products, and we support the current range of concentrations to easily and safely dose young children," she comments.

"We remain committed to continuing our efforts to promote the safe use of acetaminophen."
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Title Annotation:Focus; Food and Drug Administration
Comment:FDA acts on painkiller risk.(Focus)(Food and Drug Administration)
Publication:Chain Drug Review
Geographic Code:1USA
Date:Jul 20, 2009
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