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FDA to propose pain med restrictions

Silver Spring, Md. – The U.S. Food and Drug Administration will recommend a more restrictive classification of certain pain medications prescribed by physicians and dentists to "increase the controls on these products." The decision could lead to a reclassification by the Drug Enforcement Administration of hydrocodone-containing combination drug products such as Vicodin.

"Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency's intent to recommend to HHS (U.S. Department of Health and Human Services) that hydrocodone combination products should be reclassified to a different and more restrictive schedule," the FDA said in a statement posted at the agency website.

"This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which we received input from a wide range of stakeholders, including patients, health care providers, outside experts and other government entities."

Narcotic analgesics, such as hydrocodone and oxycodone, have become a leading source of drug abuse among teens and adults.

The FDA "has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States," the announcement said. "While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse."

The ADA and American Association of Oral and Maxillofacial Surgeons told federal regulators in a joint statement that the proposed reclassification from Schedule III to the more restrictive Schedule II "could cause inconvenience, unnecessary suffering and higher out-of-pocket costs for patients with a legitimate need" for the medications.

The ADA invites patients to visit MouthHealthy.org/rxabuse to learn more about keeping prescription drugs from becoming a source of harm. "As prescribers of these painkilling medications, dentists have a key role to play in preventing their diversion, misuse and abuse," the Association said at ADA.org.

"By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II," the agency said. "We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.

"Going forward, the agency will continue working with professional organizations, consumer and patient groups and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most," the FDA said.