A powerful new painkiller that experts say is ripe for abuse would be banned, under legislation introduced by Rep. Stephen Lynch.
The Massachusetts Democrat's bill would withdraw the Food and Drug Administration's approval of Zohydro, the first commercially available pure form of hydrocodone - the main ingredient in drugs like Vicodin.
Zohydro was approved without safeguards to make it tamper-resistant. It's up to 10 times more potent than Vicodin.
The FDA approved the drug in October despite objections from its own advisory board and addiction experts who were already calling it the next OxyContin and worried that it would unleash a similar wave of abuse, overdoses and crime. Zohydro hit pharmacy shelves last week.
OxyContin was introduced in 1995 to treat patients suffering from severe pain. But illicit users quickly found ways to override the drug's timed-release mechanism by crushing the pills into powder and then snorting or injecting the drug. In 2010, OxyContin's maker, Purdue Pharma, reformulated the drug so pills become gooey if crushed.
"Zohydro ER is a high-dose hydrocone-only opioid narcotic painkiller that does not have an abuse deterrent formulation," Lynch said. "Allowing access to a drug so powerful, without this critical component, creates risks for the public drug we simply cannot afford.
The FDA recently has taken positive steps in the regulation of opioids, including reclassifying hydrocodone combination products such as Lortab and Vicodin to a more restrictive Schedule II drug and updating labeling requirements for all extended release/long acting (ER/LA) opioid analgesics. However, this is a giant step backwards at a critical time when prescription drug abuse has fast become a rampant problem across the nation. We cannot afford to allow yet another highly addictive opioid into the mainstream and potentially onto Main Street America.
Politix and via lynch.house.gov.