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FDA Close to Restricting Access to Hydrocodone-based Painkillers

Oct 30, 2013

After nearly a decade of being urged to do so, federal health officials are now close to recommending stricter access to hydrocodone-based painkiller drugs such as Vicodin.

Based on our previous reports, Vicodin and other hydrocodone drugs are among the most prescribed and the most often abused prescription painkillers on the market. For nearly a decade, lawmakers, other federal agencies and public health advocates have been urging the U.S. Food and Drug Administration (FDA) to restrict access to these Class III drugs by reclassifying them as Class II.

Earlier this month, we reported that one U.S. Senator specifically has been calling for an investigation into the alleged role played by the makers of these prescription drugs to keep Vicodin and other hydrocodone-based painkillers listed as a Class III drug. Fewer restrictions could mean more sales.

Now, Bloomberg News recently reported that the FDA has agreed to recommend the reclassification of Vicodin and other hydrocodone-based drugs as Class II drugs. The designation indicates that regulators view these drugs as posing a greater risk of addiction, and are more likely to be abused.

The FDA’s change in policy will likely take effect this December, according to the Bloomberg report. The Drug Enforcement Agency has recommended that the FDA also restrict access to refills on the hydrocodone drugs. If the FDA were to take these recommendations, patients who are prescribed these drugs would get a 90-day supply refill, compared to five refills over a six-month period as current restrictions allow.

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