Vt. issues emergency rule to restrict newly approved painkiller - WCAX.COM Local Vermont News, Weather and Sports-

Vt. issues emergency rule to restrict newly approved painkiller

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His State of the State address made national headlines. Now, Gov. Peter Shumlin is in the spotlight again taking on opiate addiction and the Food and Drug Administration. He worries a new drug will increase overdose numbers.

It's a small, but potent pill causing big concerns.

"One might wonder if they are on the same planet," said Dr. Harry Chen, Vt. Health Commissioner.

They being the FDA. Its approval of a new painkiller called Zohydro led to a new emergency rule in Vermont.

"I think they got this one wrong," said Barre Mayor Tom Lauzon.

Mayors of cities across Vermont and the state's health commissioner joined the governor to announce new requirements for doctors prescribing Zohydro.

"We've got to get ahead of this new, highly potent drug," said Dr. Chen.

Zohydro is a high-dose, extended-release narcotic up to 10 times more powerful than other drugs, like Vicodin or Oxycontin and it isn't tamper proof which means capsules can be crushed and more easily abused.

"This just defies common sense," said Shumlin, D-Vermont. "Why would we approve an even stronger opiate with no tamper resistance when we know that's how we got into this mess in the first place?"

Shumlin made fighting opiate abuse his top priority during his State of the State address, calling it an epidemic.

Since 2000, Vermont has seen an 800 percent increase in opiate drug abuse and in 2012, 54 Vermonters died from accidental opiate overdoses.

"We've got an opiate problem in Vermont and in America," said Shumlin.

He reiterated his concerns and laid out the new rules Vermont doctors must now abide by or face losing their licenses.

The new emergency rules tighten doctors' prescribing powers. Zohydro can only be given to patients if there are no alternatives, doctors must complete risk assessments, and patients must sign an agreement submitting to regular medical evaluations including urine screening.

"We feel this is the fastest way we can effectively ensure that we don't create another Oxycontin-driven opiate crisis with this particular FDA approved drug," said Shumlin.

The governor worries an outright ban could lead to costly litigation with the drug's maker, which says this medication is needed for people with chronic pain and that it's committed to its safe and appropriate use. Massachusetts has banned the drug.

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