The high rates of abuse of hydrocodone combination painkillers such as Vicodin show doctors aren’t taking seriously enough the risks of the pills, a top Drug Enforcement Administration official said.
“This drug has got a hold of this society and it’s killing us,” Joseph Rannazzisi, deputy assistant administrator in the DEA’s office of diversion control, said at a Food and Drug Administration advisory meeting today in Silver Spring, Maryland. “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.”
The FDA advisers are debating the DEA’s request to limit prescriptions of hydrocodone combination pills and cough suppressants to a 90-day supply instead of the current five refills within six months. The proposal also would strip physician assistants and nurse practitioners of their authority to prescribe the products.
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 and, as a result, has more restrictions on sales.
The advisory panel is scheduled to vote tomorrow on a recommendation at the conclusion of the two-day meeting.
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 today’s meeting. The DEA resubmitted its request in 2009.
“I think it’s obvious the two agencies have a disagreement,” Rannazzisi said. “They don’t have the luxury of seeing what I see.”
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.
The West Coast tends to use more hydrocodone than the East Coast. In 2010, 159,000 hydrocodone tablets were sold on average to California pharmacies compared to 60,000 in New York pharmacies on average the same year, Rannazzisi said.
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.
Panel members and public speakers also questioned whether changing the classification on the drugs 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 currently 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 keel with competitors.
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.
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