FDA Panel Backs Tighter Controls on Vicodin

FDA Panel Backs Tighter Controls on Vicodin

images2An advisory panel for the Food and Drug Administration has recommended tighter controls on Vicodin and other hydrocodone products, the most widely used and abused narcotic painkiller in the U.S.

The FDA panel of drug safety experts voted 19-10 in favor of reclassifying hydrocodone from a Schedule III controlled substance to a Schedule II drug, which will make it harder for pain patients to obtain or get refills for. The FDA usually follows the recommendations of its advisory panels.

“We will pay close attention to everything we’ve heard as we proceed,” FDA deputy director Douglas Throckmorton told the panel at the end of two days of hearings. “There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society,”

Reclassification of hydrocodone was rejected by the FDA in 2008, but the Drug Enforcement Agency asked the agency to reconsider because of rising rates of hydrocodone abuse. In 2008, federal health officials say 89,000 people went to hospital emergency rooms after overdosing on hydrocodone. By 2010, the number had grown to over 115,000, according to the Substance Abuse and Mental Health Services Administration.

“I don’t think reclassification is a panacea for the opioid abuse problem in this country, but I think it’s an important step to get doctors to rethink their prescribing practices,” said Mary Ellen Olbrisch, an advisory panel member and professor at Virginia Commonwealth University who voted for the reclassification.

Hydrocodone is often combined with other pain relievers such as acetaminophen and aspirin to make combination products like Vicodin. In 2011, U.S. doctors wrote over 131 million prescriptions for hydrocodone products, making it the most prescribed drug in the country.

As a Schedule III drug, a 30-day prescription for Vicodin can be refilled five times before a patient has to see a physician again. If hydrocodone is reclassified, a doctor could only write a single 30-day prescription for Vicodin. No refills will be allowed unless a patient sees a doctor again and a new prescription is written. The drug could also not be prescribed by nurses and physician assistants.

“Rescheduling the products to Schedule II would create significant hardships for all — leading to delayed access for vulnerable patients with legitimate chronic pain,” the National Community Pharmacists Association said in a statement.

According to the Centers for Disease Control and Prevention, opioid painkillers, such as Vicodin and OxyContin, cause 75% of prescription drug overdoses. Painkiller abuse and addiction is common and there is a lucrative black market for the drugs. At the same time, however, there are 100 million Americans who suffer from chronic pain who obtain the drugs legally through prescriptions. For many, life would be difficult, if not impossible, without access to opioid medicines.

Authored by: Pat Anson, Editor