A federal advisory panel whose purpose it is to guide the U.S. Food and Drug Administration (FDA) in establishing drug labeling and marketing policy has urged the agency to step up its labeling requirements for the popular painkiller Vicodin (hydrocodone) following a trail of dead patients. According to the Los Angeles Times (LAT), the panel voted 19-10 recently to recommend that the FDA reclassify hydrocodone combination drugs as Schedule II narcotics, which would put them in the same strict category as OxyContin (oxycodone) and other widely abused prescription drugs.
Drugmakers are hoping that their newer drugs could help offset the revenue lost from former top-sellers.
Hydrocodone as it is currently sold in specialized drug blends, is designated by the federal government as a Schedule III drug, which is considered less addictive and dangerous than a Schedule II drug. But because hydrocodone use is now linked to causing as many as 50,000 deaths in the U.S. every single year -- there were nearly 1,000 deaths from hydrocodone just in Southern California during the five-year period between 2006 and 2011 -- authorities are concerned that patients are too easily accessing and abusing the drug.
"If the FDA approves the change, patients would be able to get fewer hydrocodone pills at one time, and there would be more restrictions on refills," explains Lisa Girion from LAT about the implications of the panel's recommendations, should they be enacted. "In addition, pharmacies would have to follow stricter procedures for handling and storing the drug."
According to the latest available data, hydrocodone drugs are the most prescribed painkillers in America today. In 2010, there were 131 million prescriptions for hydrocodone drugs, which include not only Vicodin, but also Norco and Lortab. But officials from the U.S. Drug Enforcement Administration (DEA) say this is unacceptable, and that many of these prescriptions are inappropriate or invalid. Thousands of doctors, it turns out, remain largely unaware of how dangerous and addictive hydrocodone can be, and officials say this is because the drug is inadequately regulated.
"Most doctors are under the impression that Vicodin (whose main ingredient is hydrocodone) is less addictive than other prescription painkillers," said Dr. Andrew Kolodny, President of the group Physicians for Responsible Opioid Prescribing (PROP), to CNN. "When you wonder why your dentist gives you 40 hydrocodone for a toothache, or your knee doctor prescribes far more than he should, that's because they're under the impression that it's not as addictive as Percocet. That's completely false."
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