Schumer seeks reversal of FDA approval of potent painkiller

Sen. Charles Schumer, at a March 3, 2014, news conference, calls on the Department of Health and Human Services to overturn an FDA decision that would allow the powerful opioid painkiller Zohydro to enter the market. (Credit: News 12 Long Island)

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Sen. Charles Schumer is calling on the Health and Human Services secretary to overturn the government's approval of a new powerful prescription opioid, Zohydro ER, until it has been made abuse-proof.

In a news conference at Zucker Hillside Hospital in Glen Oaks Tuesday, the New York Democrat said he believed there was a "decent chance" that HHS Secretary Kathleen Sebelius would overturn the Food and Drug Administration's approval in October of the pure hydrocodone painkiller. The drug, said to be up to 10 times stronger than Vicodin, went on the market this weekend.

"We've communicated," he said. "She understands the evidence is overwhelming."

Zohydro, like many highly addictive opioid pills designed to release a drug over time, can be easily crushed and snorted by addicts seeking a stronger, faster high.

An HHS spokesman said the agency will respond to Schumer's concerns.

The FDA approved Zohydro in October despite the 11-2 recommendation of its advisory panel against it.

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Hydrocodone belongs to the highly addictive opioid family that includes morphine, codeine, methadone and oxycodone, which officials say is the region's most abused drug. Unlike Zohydro, oxycodone, the drug in the painkiller OxyContin, has since 2010 been sold in pills that can't be crushed into powder, which experts say has helped reduce abuse.

Schumer said allowing Zohydro on the market "is bad enough," but not making it abuse-proof "was adding insult to injury."

"This is a giant step backward," he said.

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The company that makes Zohydro, Zogenix, has said it is developing an abuse-proof version of the drug, and last month it announced it was forming an "external safe-use board" of outside experts to monitor the use of Zohydro ER.

Jeffrey Reynolds, executive director of the Long Island Council on Alcoholism and Drug Dependence, who testified against approval of Zohydro before the FDA advisory panel, said he was baffled by the FDA's decision. Zohydro "might be a godsend for those with chronic pain," he said, but in terms of its potential for abuse, "it's a disaster."

Two women affected by prescription drug abuse in different ways said they were also worried.

"It's just an absurdity," Laura Bustamante of Medford said of the FDA's approval. Her father, Bryon Sheffield, was one of four people gunned down on Father's Day 2011 in a Medford pharmacy by David Laffer, who was seeking pain pills for himself and his wife, Melinda Brady.

Joni Kovacs-Howe of Hicksville lost her 22-year-old son Steven to a drug overdose in 2009. "Zohydro will kill even more," she said.

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