Fibro Daily

FDA Panel Approves Tighter Vicodin Restrictions

Fibro Daily January 27, 2013

An advisory committee of the Food and Drug Administration (FDA) approved tighter restrictions that will move hydrocodone combination drugs—including Lortab, Norco, and Vicodin— into the schedule II category of controlled substances.

After a two day process, the panel voted this past Friday, 19-10. The decision was based on awareness about the abuse of and death from these drugs.

In the piece FDA Panel Votes for Tighter Controls on Vicodin by Kristina Fiore, staff writer for Med Page Today, one of the panelists explains the decision further:

“We’ve seen the terribly serious consequences of poor prescribing practices stemming from obvious misclassification of hydrocodone combinations,” said panelist Mary Ellen Olbrisch, PhD, professor of psychiatry at Virginia Commonwealth University.

“I don’t think the reclassification is a panacea for the opiate abuse problem in the U.S.,” she added, “but I think it’s an important step in getting physicians to rethink prescribing practices and look at other approaches to pain management.”

This decision means that a written prescription is mandatory for these drugs now and it cannot be written for more than a three month supply.

Pain patient advocates worry this will put pain patients in dire circumstances. Whether or not this will lead to new innovative ways to deal with pain remains to be seen.



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