FDA panel votes for more restrictions on Vicodin

WASHINGTONFederal health advisors want new restrictions on hydrocodone, the highly addictive ingredient found in Vicodin and other widely abused prescription painkillers.

The Food and Drug Administration's panel of drug safety specialists voted to subject hydrocodone drugs to the same restrictions as narcotics like oxycodone and morphine.

The panel voted 19-10 in favor of the move, which is supported by the Drug Enforcement Agency. The FDA will weigh the vote in its decision-making process.

Hydrocodone is sold in combination pills like Vicodin, which mixes the drug with non-addictive painkillers like acetaminophen. The drug belongs to a family of drugs known as opioids, which include morphine, heroin, oxycodone, codeine and methadone.

Doctors prescribe the medicines to treat pain from injuries, surgery, arthritis and other ailments such as coughs.

Hydrocodone consistently ranks as the first or second most-abused medicine in the U.S. each year, according to the Drug Enforcement Agency.

Panelists who voted for new restrictions said it would send a signal to doctors about the potential dangers of hydrocodone drugs.

"I don't think reclassification is a panacea for the opioid abuse problem in this country, but I think it's an important step to get doctors to rethink their prescribing practices," said Mary Ellen Olbrisch, a professor at Virginia Commonwealth University.

The DEA has asked the FDA to reclassify hydrocodone as a schedule II drug, limiting which kinds of medical professionals can write a prescription and how many times it can be refilled. The Controlled Substances Act, passed in 1970, put hydrocodone combination drugs in the schedule III class, which is subject to fewer controls.

• Painkiller 10 times stronger than Vicodin worries addiction experts
• Painkillers behind surge of drug-addicted babies
• Analysis: High prevalence of painkiller sales turning America into painkiller nation

An April, 2012 Drug Enforcement Administrationreport showed that 42 tons of pure hydrocodone were prescribed across U.S. pharmacies in 2010, enough to give 24 5-milligram Vicodins to every person in the United States.

In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country.

Currently a prescription for hydrocodone-containing Vicodin can be refilled five times before the patient has to see a physician again. If the drug is reclassified patients could only receive a single 90-day prescription, similar to oxycodone. The drug could also not be prescribed by nurses and physician assistants.

Panelists who voted against the classification change said it would have unintended consequences, driving addicted patients to obtain the drugs illegally.

"If prescribing decreases, illicit opioid use will increase, with dire consequences," said Dr. John Mendelson, of St. Luke's Hospital in San Francisco. "I think this is a mistake and we will be back here with other problems."

Several physician and pharmacist groups also argued that new restrictions would burden medical professionals and disrupt patient care.

"Rescheduling the products to Schedule II would create significant hardships for all - leading to delayed access for vulnerable patients with legitimate chronic pain," said the National Community Pharmacists Association, in a statement.

The FDA is not required to follow the advice of its expert panelists, though their input is often critical in its decisions.

FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them.

"There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society," said Douglas Throckmorton, FDA's deputy director for regulatory programs.