FDA urges tighter painkiller restrictions
FDA Urges Tighter Controls on Certain Prescription Painkillers
HealthDay News -- The FDA is calling for tighter controls on hydrocodone combination prescription painkillers, including Vicodin, recommending that they receive the same Schedule II classification as the narcotics OxyContin and fentanyl.
The restrictions will eliminate a clinicians' ability to prescribe up to a six-month supply of the drug, as well as their ability to call in prescriptions for these types of medications. According to the Schedule II classification, healthcare providers can write no more than a three-month supply, for which a written prescription is mandatory.
"This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which we received input from a wide range of stakeholders, including patients, healthcare providers, outside experts and other government entities," the FDA said in a Drug Safety Communication.
The FDA will send its formal recommendation to the U.S. Department of Health and Human Services (HHS) in early December, and the Drug Enforcement Administration will make the final change in a process that could take more than a year to be finalized.
The action comes after years of disagreement over how much leeway doctors should have in prescribing the often-abused drugs. The New York Times reported that the move indicates a major policy shift on drugs that combine hydrocodone with OTC pain medicines like aspirin or acetaminophen.
Currently, hydrocodone painkillers are less tightly monitored than more powerful painkillers such as OxyContin. The U.S Drug Enforcement Agency has pushed for the new recommendation, while some medical groups and pharmacy organizations have opposed it because of the effect on patients, the Times reported.