FDA Panel Wants More Restrictions on Hydrocodone

By Fran Lowry
Medscape Medical News

Jan. 28, 2013 -- It may become more difficult to get prescriptions for drugs containing hydrocodone combined with other pain relievers.

An FDA panel voted 17 to 10 in favor of reclassifying hydrocodone-containing compounds, such as Vicodin, from Schedule III drugs under the Controlled Substances Act to Schedule II, which means it would be considered to have an even greater potential for abuse.

The drug is also found in prescription drugs Norco and Lortab.

The panel heard testimony for and against the move over two days. Those in favor emphasized hydrocodone's potential for addiction and abuse, and those against warned that millions of legitimate pain patients would suffer if it becomes more difficult to obtain.

The vote sends a strong message to doctors and the public about the abuse potential of hydrocodone combination products, many on the panel felt. Several said that death rates from hydrocodone-combination-drug overdoses have tripled over the last two decades

"Clearly the data shows the magnitude of the epidemic of misuse, abuse, and diversion of prescription narcotics," said Elaine Morrato, DrPH, from the University of Colorado School of Public Health. Morrato voted for the measure.

She said she was hopeful that "appropriate remedies" would be put in place should the changes take place, "so that those who are disadvantaged, such as those who are in rural settings or who may have access problems, aren't disproportionately affected by the change."

Curbing Early Abuse

"There is clear and compelling evidence that there is severe dependence on these medications among those who abuse them," said William Cooper, MD, MPH, professor of pediatrics and preventive medicine at Vanderbilt University School of Medicine.

He added that, as a pediatrician, "I would urge us from the public health perspective to be mindful that much of our data suggest abuse can begin in adolescents and young adults, and we need to think carefully about prevention measures in this age group and do what we can to prevent this scourge."

Melinda Moore, a physician assistant from Webster, Texas, said she feared that the burden to patients, especially in rural areas, would grow.

"The inability to call in prescriptions for the hydrocodone combination was one of my major problems with rescheduling," she said.

Moore stressed the importance of monitoring drug use and said that monitoring programs should work across state lines. She also suggested using electronic prescribing.

More Concerns Voiced

John Mendelson, MD, from St. Luke's Hospital in San Francisco, said he thought the change would lead to more prescribing of other drugs, “which may have greater abuse liability and actually fuel, rather than reduce, an epidemic in progress. Illicit opiate use will increase with dire consequences.”

He said he was also concerned that some people who take the drugs would be forced into a withdrawal.

"We have already heard from dramatic testimony today exactly how dangerous abrupt opiate withdrawal is with later [return] to opiate abuse. At least two of the deaths that we heard about today were directly related to those issues."

The change must be approved by the FDA and the DEA to take effect.

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SOURCE:Center for Drug Evaluation and Research, Meeting of the Drug Safety and Risk Management Advisory Committee, Silver Spring, Md., Jan. 24-25, 2013.

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