FDA Might Tighten Reins on Vicodin
Published: Jan 11, 2013
The DEA for nearly a decade has pushed for tighter restrictions on Vicodin, the nation's most widely prescribed drug. The chronic abuse of such painkillers, and devastating toll associated with this abuse, has reached epidemic proportions in the United States. The agency could get its wish later this month when the Food and Drug Administration considers the DEA's request to put Vicodin in the same category as OxyContin and other powerful narcotics. A recommendation from the FDA has proven elusive and is far from certain, but such a reclassification would allow the Drug Enforcement Administration to elevate the powerful painkillers from Schedule III to Schedule II, the most restrictive category of medically accepted drugs. For the millions of patients across the nation who rely on Vicodin for relief from severe pain, the new rules could sharply restrict the number of pills they can get and drastically increase the number of doctor visits necessary to get them. Many patients who can now get a six-month supply would need to visit their doctors every 30 days to renew a prescription. The Centers for Disease Control and Prevention calls prescription painkiller abuse an epidemic. Opioid painkillers, such as Vicodin and OxyContin, cause 75% of prescription drug overdoses, the CDC says. In recent years, such overdoses have outpaced cocaine and heroin deaths combined, the CDC notes. "This is a real problem for the country," said Lynn Webster, president-elect of the American Academy of Pain Medicine and a board-certified anesthesiologist. He will speak before the FDA committee that meets Jan. 24-25 to consider the DEA's request. This is the DEA's second attempt to get the FDA to elevate the powerful painkillers from Schedule III to Schedule II. In 2008, the FDA rejected the DEA's initial request submitted in 2004. The reasoning: The hydrocodone combination drugs have less potential for abuse than the other drugs in Schedule II, including oxycodone.