Vicodin and other hydrocodone-based painkillers, the most popular pharmacy drugs in the U.S., would be placed under stricter prescribing limits to curb abuse, in a policy reversal by the Food and Drug Administration.
The FDA agreed to recommend by early December reclassifying the pills as a Schedule II substance, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said in a statement. Hydrocodone combinations, are currently Schedule III, the third-highest level on a five-stage scale that takes into account the potential for addiction.
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 report released in January. The Drug Enforcement Administration for about a decade has been asking the FDA to recommend reclassifying the products to Schedule II from III, including in 2004, a request the FDA denied in 2008. The DEA resubmitted its request in 2009.
“While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” Woodcock said yesterday.
The FDA said it anticipates the National Institute on Drug Abuse will side with its recommendation, as will the DEA. A phone call to the DEA for comment wasn’t returned.
The restrictions may make it tougher for pain patients, said Edward Michna, assistant professor at Harvard Medical School, and director of the Pain Trials Center at Brigham and Women’s Hospital in Chestnut Hill, Massachusetts. In some states, nurse practitioners can’t write prescriptions for Schedule II drugs and many doctors aren’t willing to prescribe anything stronger than Schedule III, he said by telephone.
“So you have to consider the secondary, unintended consequences: patients who are legitimate users who may lose access, or be restricted,” Michna said. “It’s all a balance.”
Hydrocodone combinations join the main ingredient with less potent painkillers such as acetaminophen or ibuprofen. A panel of FDA advisers in January called for tougher restrictions on the drugs because of the potential for abuse. Lawmakers have also called for the change.
“Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs,” U.S. Senator Chuck Schumer, a New York Democrat, said in a statement. “I’m very pleased that the FDA has heeded my call and will tighten up control of one of the most highly prescribed -- and abused -- drugs on the market.”
Schumer called on the FDA in January to tighten controls on the drugs to “combat an unprecedented spike in prescription drug abuse in New York state and the country,” according to his statement.
The DEA had asked FDA to recommend the Schedule II reclassification that would limit refills to a 90-day supply instead of the current five refills within six months.
The decision may also level the playing field for Zogenix Inc. (ZGNX:US), which is awaiting word from the FDA on whether the agency will approve for sale the company’s pure hydrocodone painkiller Zohydro. Pure hydrocodone products are already classified as Schedule II, and the FDA recommendation would put some of the same restrictions on Zogenix’s competition.
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