FDA Panel Advises Tighter Restrictions on Hydrocodone Painkillers

On January 25, 2013, an FDA advisory panel voted 19 to 10 to tighten restrictions on hydrocodone combination painkillers such as Vicodin, Lortab, and Norco. The agency is thought to be likely to follow the panel’s recommendation, although it has rejected similar advice in the past.

The new rules would move hydrocodone combination painkillers from the Schedule III category of controlled substances to Schedule II. As a result, a written prescription from a doctor would be required to dispense the medications, no refills could be dispensed without a new prescription, and providers would be able to prescribe at most a 3-month supply of medication, down from the current 6-month limit.

The proposed restrictions are part of a general trend toward more conservative use of opioid painkillers in reaction to alarmingly high rates of overdose and death attributed to them. Prescription drugs are behind three-fourths of all drug overdose deaths in the United States, and since 2008, painkillers have caused more deaths than car accidents.

Opponents of the restrictions argue that they will pose unfair obstacles to chronic pain patients who need painkillers and will either be ineffective at reducing abuse or prompt abusers to turn to alternatives such as heroin.