Arizona among 28 states to ask FDA to rethink painkiller approval
More than two dozen state prosecutors, including Arizona's, are asking the Food and Drug Administration to reconsider its approval of a powerful new painkiller called Zohydro, saying that the narcotic pill could add to the national epidemic of prescription drug abuse.
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#1 Dec 12, 2013
Again, good for the AG's; because this approval reeks, and its stench is rotten. This is another "me too" drug, but the abuse potential of this drug is only going to produce a better batch of liars, and many more than exist in the system now. I do not wish to paint everyone with this “broad brush,” but "many" will be willing to sell their soul for a taste of the Zohydro high. Zogenix will argue Vicodin is dangerous because acetaminophen is hard on the liver, it can cause liver damage. This is a ridiculous argument, if you think about it a moment the only reason acetaminophen is going to affect the liver is by taking more Vicodin than prescribed. Additionally, the liver is a strong organ, it will recover quickly from medium-term acetaminophen use; moreover, pain docs will monitor liver health during treatment. What pain docs do not possess is a lie detector. Their only system of control is to ask patients, what is your pain level between 1 and 10? Does anyone really believe the Doc, or PA, will get a valid response to this question? The only other safeguards docs have is a blood, or urine test, or if someone is stupid enough to answer YES to the question, do you use (or have you used) recreational drugs? Regardless, blood and urine tests should be performed every 60 - 90 days if opioids are onboard. The danger that patients will experience respiratory failure at some point (long term usage, or stop and start usage as the effect is cumulative), should be by itself be the reason for this drug's denial. Please, Please, Please investigate how, why, and which individuals were responsible for approving this drug, as accountability is a necessity in this situation. By the way, despite the fact that an antagonist may/or may not be in Zohydro's future, it will not be in Zohydro's immediate future, it will be years before an abuse deterrent is perfected and placed into this drug's core. The fact Zogenix has noted this and its partnership is simply for effect, it is smoke and mirrors and nothing else. Investigate and do not hesitate. Another point worth noting is Zohydro is classified a schedule 2 drug; however, so are all the other drugs that are known to be semi-effective in masking pain. The Schedule 2 moniker has blanketed this class of drugs for a long time, an important clue to its actual effectiveness. Please do everyone in the country a favor. Investigate without delay.
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