28 states ask FDA to rethink painkiller approval

AP News
Posted: Dec 12, 2013 12:40 PM

WASHINGTON (AP) — State prosecutors are asking the Food and Drug Administration to reconsider its approval of a powerful new painkiller called Zohydro, saying that the narcotic pill could add to the national epidemic of prescription drug abuse.

The FDA approved Zohydro in October, making it the first single-ingredient hydrocodone drug available in the U.S. The extended release pill is reportedly five to 10 times more potent than currently available hydrocodone combination pills, like Vicodin. The agency's decision surprised many doctors, since an FDA advisory panel voted overwhelmingly against the drug, citing its potential for abuse.

The letter from 28 state attorneys general asks the FDA to revoke the drug's approval or require manufacturer Zogenix to reformulate the drug so it is harder to abuse.

Zogenix did not immediately return calls for comment.