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FDA Panel Wants More Restrictions on Hydrocodone

By Fran Lowry
Medscape Medical News

Jan. 28, 2013 -- It may become more difficult to get prescriptions for drugs containing hydrocodone combined with other pain relievers.

An FDA panel voted 17 to 10 in favor of reclassifying hydrocodone-containing compounds, such as Vicodin, from Schedule III drugs under the Controlled Substances Act to Schedule II, which means it would be considered to have an even greater potential for abuse.

The drug is also found in prescription drugs Norco and Lortab.

The panel heard testimony for and against the move over two days. Those in favor emphasized hydrocodone’s potential for addiction and abuse, and those against warned that millions of legitimate pain patients would suffer if it becomes more difficult to obtain.

The vote sends a strong message to doctors and the public about the abuse potential of hydrocodone combination products, many on the panel felt. Several said that death rates from hydrocodone-combination-drug overdoses have tripled over the last two decades

"Clearly the data shows the magnitude of the epidemic of misuse, abuse, and diversion of prescription narcotics," said Elaine Morrato, DrPH, from the University of Colorado School of Public Health. Morrato voted for the measure.

She said she was hopeful that "appropriate remedies" would be put in place should the changes take place, "so that those who are disadvantaged, such as those who are in rural settings or who may have access problems, aren’t disproportionately affected by the change."

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