FDA Panel Votes to Toughen Restrictions on Hydrocodone Combination Drugs

A Food and Drug Administration (FDA) advisory panel voted Friday to strengthen restrictions on hydrocodone combination drugs, such as Vicodin. The panel recommended that the FDA make the drugs more difficult to prescribe.

Supporters of the panel’s recommendation say it could help reduce addiction to painkillers, The New York Times reports. The agency is likely to adopt the panel’s proposal, the article notes.

The panel made the recommendation in a 19-to-10 vote. Opponents were skeptical the proposal would be effective against prescription drug abuse. They also were concerned the changes would make it more difficult for patients in chronic pain to obtain relief. At the two-day FDA hearing about the proposal, opponents noted it would require frail nursing home residents to make a trip to the doctor’s office to obtain pain prescriptions.

The proposal forbids refills without a new prescription, as well as faxed prescriptions and those called in by phone. Distributors of the drugs would have to store the drugs in special vaults. Nurse practitioners and physician assistants would be banned from prescribing the drugs.

Some panelists said the proposal could have the unintended effect of increasing abuse of other drugs, such as heroin.

“Many of us are concerned that the more stringent controls will eventually lead to different problems, which may be worse,” said Dr. John Mendelson, a senior scientist at the Addiction and Pharmacology Research Laboratory at the California Pacific Medical Center Research Institute in San Francisco.

The FDA convened the panel at the request of the Drug Enforcement Administration. If the FDA accepts the panel’s recommendation, it will be sent to the Department of Health and Human Services, which will make the final decision.

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    Michael W. Shore, M.D.

    January 28, 2013 at 12:59 PM

    As an Addiction Psychiatrist on the “front lines” of treating opiate addiction, I say unequivocally “IT IS ABOUT TIME”. Rescheduling hydrocodone as a harder to obtain Schedule II drug will indeed help to reduce it’s abuse. Legitimate pain patients are not going to turn to Heroin, and nursing home falls, with the high morbidity associated with it will be reduced if physicians need to write ‘scripts (and presumably reevaluate the patient)on a monthly basis. It is not necessary to bundle up frail patients to take to the doctors office monthly – they can be seen on site by the staff physician. Dr. Shore

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