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Controversy surrounds FDA approval of powerful new painkiller

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JOHNSON CITY, TN (WJHL) - It could be the most controversial drug you've never heard of: Zohydro - five to ten times stronger than Vicodin. The powerful new extended-release pain killer (taken once every 12 hours) is pure hydrocodone - the first of its kind to hit the market.

In October 2013, the FDA approved Zohydro. It's a move 29 state attorneys general, including Tennessee, ask to be reconsidered. This,  as Tennessee is fighting to pull back the reins on the raging prescription drug abuse epidemic.

"I think it grabs people's attention because there's this complex back and forth between appropriate pain control - but the worry about addiction, as well as overdose deaths that can happen when someone takes too much opioids,"  Sara Melton, Associate Professor with the Gatton College of Pharmacy at East Tennessee State University said.

When discussing the region's prescription drug abuse epidemic, consider this: According to the International Narcotics Control Board, though the United States only comprises 5 percent of the world's population, it now consumes more than 99 percent of the hydrocodone supply.

In December, 29 state attorneys general signed a letter asking the FDA to reconsider Zohydro's approval.

Included in the letter:

"We believe your approval of Zohydro ER has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties."

"In other words, it's an extended release capsule that can easily be opened, crushed, or combined with a diluents and injected," Melton explained.

Not to mention, one pill is reportedly strong enough to kill a child. Even the FDA's own advisory committee voted 11-2 against approving Zohydro.

So what's the up side?

"Up until last year when Zohydro was approved, hydrocodone was only available in combination with Tylenol, or acetaminophen, so patients that have to take multiple doses of medicines like Lortab or Norco or Vicodin, get an excessive amount of Tylenol, which Tylenol is very irritating to the liver and can cause toxicity. And you can imagine even patients who take it normally, we worry about that, but in patients that abuse hydrocodone, they were getting a lot of Tylenol overdoses - you die from the tylenol toxicity if you hadn't died from the opioid overdose. And this provides an opportunity to provide a medication that is just straight hydrocodone without the Tylenol component with it," Melton explained.

Zohydro prescription bottles have a cap lock at the top, which requires entering a numerical code.

"It really has a warning that you get right when you open a package insert, that tells about the dangers associated with the medications," Melton said.

Melton told News Channel 11 that in Virginia, only around 70 prescriptions have been dispensed for Zohydro since it was approved.

"I think the healthcare community is being very cautious," Melton said.

Included in the FDA's response to the state attorneys general, quote:

"The company has stated publicly that it is working to develop an abuse-deterrent formulation of Zohydro, and we will do what we can to help support that development. Until then, after careful consideration, FDA determined that the benefits of Zohydro ER outweigh its risks..."

"I think the citizens of Eastern Tennessee and Southwest Virginia remember when the first formulation of Oxycontin came onto the market, which was not abuse-deterrent and then we had a tremendous increase it its use and then abuse and then overdose deaths associated with it. So I think that's why there's such concern now with this medication, because it's foreseeable that could also occur with this medicine," Melton said.

News Channel 11's Kylie McGivern also caught up with Sullivan County District Attorney General Barry Staubus today, who said it's unfortunate Zohydro has been approved, because even though it may be effective for certain patients, the concern is it's just going to add to the pill problem and all Staubus sees that comes with it - prescription fraud, Tenncare fraud, domestic violence, robbery, and more.

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