The recent FDA approval of Zohydro, a powerful new opiate pain killer, has states rebelling over its release, stating it is much too powerful and deadly and could make the nation's heroin and prescription drug abuse worse.
On Thursday, Vermont Gov. Peter Shumlin initiated an emergency order making it harder for doctors to prescribe Zohydro, which is an extended-release drug that contains up to five times the amount of narcotic hydrocodone previously available in prescription pills.
The FDA approved Zohydro last fall, and it hit the market last month. Some public health authorities say the pills are in a form too easily crushed so that abusers can then snort or inject the drug.
"It's not like we don't have painkillers in America," Shumlin said. "We're just saying, 'Hey, we understand we don't control the FDA, but we do have some influence in Vermont.'"
Prescription drug abuse is the nation's fastest-growing drug problem, with more than 4.5 million Americans abusing pain relievers, according to a 2013 Drug Enforcement Administration report.
Some might recall that Shumlin has other "drug" related problems in his state, in January, he devoted the bulk of his State of the State address to Vermont's "full-blown heroin crisis."
Massachusetts Gov. Deval Patrick went even further last week, ordering an outright ban on prescribing and dispensing Zohydro until it is marketed in a form that is difficult to abuse.
“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large,” Governor Patrick said in a news release.
The hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain.
"In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid," the coalition to end opioid addiction wrote in a letter to FDA Commissioner Dr. Margaret Hamburg, entitled "Fed-Up".
The letter included, "Too many people have already become addicted to similar opioid medications, and too many lives have been lost. We urge you to exercise your authority and responsibility to protect the public's health by keeping Zohydro off the market."
One addiction expert who signed the letter was a bit more candid.
"It's a whopping dose of hydrocodone packed in an easy-to-crush capsule," said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. "It will kill people as soon as it's released."
Should the FDA remove the drug from the market?
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