Pubdate: Mon, 28 Jan 2013 Source: Wall Street Journal (US) Copyright: 2013 Dow Jones & Company, Inc. Contact: http://www.wsj.com/ Details: http://www.mapinc.org/media/487 Authors: Thomas Catan And Timothy W. Martin FDA PANEL CALLS FOR NEW CURBS ON COMMON PAINKILLER WASHINGTON - Federal drug safety advisers recommended new restrictions on a type of widely used narcotic painkiller, amid concern that the drug is fueling a surge in addiction and overdose deaths. After two days of testimony, the Food and Drug Administration's drug safety advisory panel voted 19-10 to recommend that products containing hydrocodone - a category that includes Vicodin - should be reclassified as Schedule II controlled substances, along with other narcotic painkillers such as oxycodone. Hydrocodone products are currently in Schedule III. If approved, the move would change how doctors prescribe pills that are taken by tens of millions of Americans. They would be able to prescribe fewer pills at one time. The pills would also be subject to more stringent handling and storage rules. The advisory committee's recommendation isn't binding, but advocates of the move said that the margin of the vote would make it difficult for the FDA to ignore. "I believe the schedule change will mark a turning point in the epidemic," said Andrew Kolodny, a New York psychiatrist who advocates more selective use of hydrocodone and other drugs known as opioids because of their resemblance to derivatives of opium. If implemented, the changes would "help prevent these highly addictive drugs from getting into the wrong hands," said Sen. Joe Manchin, a West Virginia Democrat who proposed legislation last summer to tighten controls on hydrocodone products. A spokesman for the Generic Pharmaceutical Association, which represents several opioid manufacturers, said companies would abide by whatever the FDA decides, but he said that the change in schedule would not in itself be enough to solve the problem of abuse. According to the Centers for Disease Control and Prevention, more than 16,500 people died after overdosing on opioid-based painkillers in 2010, the most recent data available. No other class of drugs, legal or illegal, is responsible for as many deaths, its figures show. The FDA had rejected several previous requests by the Drug Enforcement Administration to reclassify hydrocodone products. The FDA and DEA declined to comment on Friday's vote. Drug safety groups and family members of overdose victims have long pushed for the move, arguing that the hydrocodone products were no less addictive or prone to abuse than more tightly controlled drugs like OxyContin. However, some pain medicine groups warned that the move could make it harder for legitimate patients to get their medications, and make doctors more reluctant to prescribe them. "I hope people in pain won't suffer as a result," said Lynn Webster, president-elect of the American Academy of Pain Medicine. The generic version of Vicodin, a blend of hydrocodone and the non-narcotic painkiller acetaminophen, is the most widely prescribed medication in the U.S., according to IMS Health Inc., which tracks pharmacy drug sales. Hydrocodone drugs are commonly prescribed to treat acute pain in patients such as those who have broken bones or undergone dental surgery. Some 47 million patients were given prescriptions for hydrocodone in 2011, according to the FDA. Americans use 99% of the world's hydrocodone supply, according to a 2005 study by the International Narcotics Control Board, which implements United Nations drug conventions. "Is hydrocodone the most abused pharmaceutical in the U.S.? Absolutely," said John Burke, president of the National Association of Drug Diversion Investigators, a nonprofit group that works with law enforcement, doctors, state and manufacturers to curb prescription drug abuse. In December, an FDA advisory panel also voted against approving the first pure hydrocodone product amid fears that it could become a widely abused drug. The FDA must also soon decide whether to intervene to stop cheap, generic copies of two widely abused drugs - OxyContin and Opana - from being marketed in the U.S. this year. The generic copies currently lack the crush-resistant formulations of the brand name drugs, potentially making them attractive to those who wish to abuse them. - --- MAP posted-by: Jo-D