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.