A Call to Revoke Zohydro Approval

Given all the recent bad news about the overuse of opioid drugs and the overprescribing practices of some physicians, it’s hardly a surprise that last week several federal lawmakers and public health advocates called on the FDA to withdraw its approval of Zohydro, a new opioid painkiller.

As reported by NPR.org, Zohydro hit the market last week, and it’s one of the most powerful prescription painkillers ever. “Swallowing just one capsule,” according to NPR, “could kill a child.”

The danger is compounded by the fact that, unlike new formulations of Oxycontin (oxycodone, a long-acting opioid) and other painkillers, Zohydro is crushable, so people can snort it for a euphoric high.

The folks lobbying for its removal are asking the FDA: What were you thinking?

After all, the agency’s own advisory panel voted 11 to 2 not to approve the drug last year.

FDA officials rejected that advice, and maybe this is why: emails were made public that showed agency officials participated in private meetings with drug companies that paid organizers thousands of dollars to attend, including Elan Corp., Zohydro’s original manufacturer.

FDA officials defended the meetings as beneficial to patients and the body of research, and that there was no undue unfluence. Sen. Joe Manchin, D-W.Va., who has proposed a bill to force the FDA to remove its approval of Zohydro, said he asked the FDA for details about those meetings almost five months ago.

In addition to the lawmakers, attorneys general from 28 states and 42 public health organizations have joined the appeal for Zohydro’s removal. FDA officials did not respond to NPR’s questions about whether they would consider such a move.

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