WASHINGTON (AP) — U.S. Sen. Joe Manchin is calling on the government's top health official to overturn the approval of a powerful painkiller, arguing that the pill Zohydro could add to the national epidemic of prescription drug abuse.
The West Virginia Democrat joins a chorus of lawmakers, state prosecutors and medical groups seeking a reversal of the Food and Drug Administration's October approval. In a letter Monday, Manchin asks Health and Human Services Secretary Kathleen Sebelius to overrule the agency's decision.
Zohydro is the first single-ingredient hydrocodone drug ever cleared for U.S. patients. The extended-release pill contains more of the narcotic pain reliever than older combination pills, such as Vicodin.
The FDA approval surprised many doctors, since the agency's own advisers voted overwhelmingly against the drug, citing its abuse potential.