FDA Panel Calls for Greater Restrictions on Hydrocodone

Fran Lowry

January 28, 2013

Drugs containing hydrocodone combined with other analgesics may soon be subject to more stringent prescribing requirements if the US Food and Drug Administration (FDA) accepts the recommendation of its expert panel to reschedule the widely used drug.

The FDA's Drug Safety and Risk Management Advisory Committee voted 19 to 10 in favor of reclassifying hydrocodone-containing compounds from Schedule III drugs under the Controlled Substances Act to Schedule II.

For 2 days, the panel heard impassioned testimony for and against reclassification, with those in favor emphasizing hydrocodone's potential for addiction and abuse, and those against warning that millions of legitimate pain patients would suffer if its availability becomes more limited.

The vote sends a strong message to physicians and the public about the abuse potential of hydrocodone combination products, many of the panel felt. Several mentioned the fact that death rates from hydrocodone combination drug overdoses have tripled during the last 2 decades

"Clearly, the data show 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, in Aurora, in explaining her yes vote.

"For me, the most persuasive argument was that rescheduling is a signal to the public as well as to the medical profession about the abuse potential, and it rights a misperception that hydrocodone combination products are safer options than class IIs when it comes to long-term risk of abuse," Dr. Morrato said.

She added that she was hopeful that "appropriate remedies" would be put in place should the rescheduling be implemented, "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

William Cooper, MD, MPH, professor of pediatrics and preventive medicine at Vanderbilt University School of Medicine, Nashville, Tennessee, also voted yes for similar reasons.

"I too considered the potential impact on patients and providers, and that is an important issue for us to consider as we move forward," Dr. Cooper said. "But there is clear and compelling evidence that there is severe dependence on these medications among those who abuse them."

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, was against rescheduling because she feared that the burden to patients, especially in rural areas, would be greatly increased.

"The inability to call in prescriptions for the hydrocodone combination was one of my major problems with rescheduling. I felt there were poor data to support the change," she said.

Moore stressed the importance of monitoring drug use and that such monitoring programs should be across state lines and widely used. She also suggested that steps such as electronic prescribing should be in all states for all schedules, including 2 through 5.

Hobson's Choice

Another strong opponent to rescheduling was John Mendelson, MD, from St. Luke's Hospital, San Francisco, California.

"This is a Hobson's choice. There is no good single choice within this vote, which is unfortunate. I believe that the net result will be increased prescribing of other C2 drugs which may have greater abuse liability and actually fuel, rather than reduce, an epidemic in progress," Dr. Mendelson said. "Illicit opiate use will increase with dire consequences."

A final complication that is likely from this vote is that some people will be abruptly withdrawn, he predicted.

"We have already heard from dramatic testimony today exactly how dangerous abrupt opiate withdrawal is with later recrudescence to opiate abuse. At least 2 of the deaths that we heard about today were directly related to those issues."

Center for Drug Evaluation and Research Meeting of the Drug Safety and Risk Management Advisory Committee, Silver Spring, Maryland, January 24-25, 2013.

processing....