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Bloomberg News

Tougher Limits on Most-Used Pain Pills Backed by Panel

January 25, 2013

Hydrocodone painkillers, the most popular pharmacy drugs in the U.S., should be placed under greater restrictions because of the potential for abuse, a government advisory panel recommended.

The Food and Drug Administration should expand limits on hydrocodone-combination pills such as Vicodin as well as cough suppressants containing hydrocodone, the advisory committee voted 19-10 today at the conclusion of a two-day meeting in Silver Spring, Maryland. The FDA, which in 2008 denied a request by the Drug Enforcement Administration for stricter regulation, must decide whether to follow the panel’s recommendation.

The DEA urged limiting prescriptions to a 90-day supply instead of the current five refills within six months, and for stripping dentists, physician assistants and nurse practitioners of their authority to prescribe the pills. About 131 million hydrocodone products were dispensed in 2011, more than double the number for oxycodone pills, which have greater restrictions, according to an FDA staff report.

“I’m appalled to see that hydrocodone is the most prescribed drug in the U.S. and that has to be something very wrong with our health-care system and society for this to happen,” said Maria Suarez-Almazor, a panelist and a professor of internal medicine at the University of Texas MD Anderson Cancer Center in Houston, who voted for more restrictions.

Abuse Potential

Hydrocodone combinations, which join the main ingredient with less potent painkillers such as acetaminophen or ibuprofen, are considered a Schedule III controlled substance, the third- highest level on a five-stage scale that takes into account the potential for addiction. Pure hydrocodone is one class higher at Schedule II and, as a result, has more restrictions on sales.

“The potential for abuse of hydrocodone-combo products is comparable with other drugs in Schedule II,” said William Cooper, a professor of pediatrics and preventive medicine at Vanderbilt University in Nashville, Tennessee, who also voted for more restrictions.

The proposal today would change the status of hydrocodone combinations to Schedule II. Those who voted against changing the schedule status cited the legitimacy of medical needs for opioids as well as the potential that illicit drug use may rise if patients have limited access to prescription pain relievers.

The DEA had asked the FDA to recommend reclassifying hydrocodone-combination products to Schedule II in 2004, a request the FDA denied in 2008, according to an FDA document released ahead of the two-day meeting. The DEA resubmitted its request in 2009.

Agency Disagreement

Joseph Rannazzisi, deputy assistant administrator in the DEA’s office of diversion control, said his agency and the FDA haven’t been seeing eye-to-eye.

“They don’t have the luxury of seeing what I see,” he said yesterday at the meeting.

Emergency department visits related to hydrocodone totaled 115,739 in 2010, more than double 2004 admissions, the Substance Abuse and Mental Health Services Administration said in a July 2 report.

“This drug has got a hold of this society and it’s killing us,” Rannazzisi said. “There’s so many prescriptions out there and I’ll tell you why. The medical community, in my humble opinion, is not taking this drug seriously.”

Abuse potential is a complex determination, Silvia Calderon, pharmacology team leader on the FDA’s controlled substance staff, wrote in a staff report released ahead of the meeting. Alternatives to reclassifying, such as education efforts and prescription drug monitoring programs, may be what is needed to curtail abuse, Calderon wrote.

Zogenix Pill

Panel members and public speakers also questioned whether changing the drug classification would change the abuse potential.

“The classification of opioids doesn’t stop misuse,” Edward Michna, director of the Pain Trials Center at Brigham and Women’s Hospital in Chestnut Hill, Massachusetts, said during the hearing. “Oxycotin is class II and it’s our most misused.”

Emergency department visits related to oxycodone products totaled 182,748 in 2010, according to the SAMHSA. Michna told the panel that the FDA invited him to speak.

Greater restrictions on hydrocodone could decrease patient access and cause a chilling effect on doctors’ willingness to provide needed hydrocodone, he said.

“It’s all about balance,” Michna said.

A change in rules for hydrocodone-combination products may benefit some companies, including Zogenix Inc., (ZGNX:US) which is developing a pure form of hydrocodone that would have to compete with less controlled substances such as Abbott Laboratories’ (ABT:US) Vicodin and generic equivalents. A change in drug schedules would put Zogenix on a more even level with rivals.

Zogenix’s pure hydrocodone painkiller Zohydro failed last month to win the backing of different FDA advisers who said the company needed to incorporate more measures into the drug to deter addicts from crushing the pills to snort them for a greater high.

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Reg Gale at

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