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The government agency charged with regulating medicine says it’s cracking down on painkiller abuse. Maybe not.
Late last month, the US Food and Drug Administration made it significantly harder for doctors to prescribe Vicodin, Lortab, and other highly addictive painkillers that have killed tens of thousands of Americans over the past decade. Lawmakers praised the agency’s move, but the next day, over the objections of its medical advisory board, the FDA approved Zohydro, a new drug that has 5 to 10 times more of the heroin-like opioid hydrocodone than Vicodin.
“If you approve this pill, you surely will be signing a death sentence for thousands of people, especially young kids,” Avi Israel, a father whose 20-year-old son committed suicide after becoming addicted to doctor-prescribed hydrocodone, told FDA officials at the December hearing.
The FDA’s advisory board, an appointed group of medical experts who evaluate drugs used in anesthesiology and surgery, voted against Zohydro 11-2 last December. As several board members noted, most opioid painkillers on the market also include acetaminophen, the main ingredient found in Tylenol, a combination that is less likely to lead to addiction. But like OxyContin, the “Hillbilly Heroin” the Drug Enforcement Agency has blamed for hundreds of deaths in a single year, Zohydro includes a high dose of its main opioid ingredient undiluted by acetaminophen. That could lead to higher rates of abuse, the FDA’s medical advisers warned.