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Potentially Lethal Pain Medication Gets FDA Approval

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FDA Approves Potentially Lethal Pain Medication Yuri Vartanov/PhotoSpin

I was listening to NPR this week and heard the announcer talking about a big medical news story that pricked up my ears. We talk to EmpowHER readers about pain medication options all the time, as well as side effects and the potential for abuse.

Now, the FDA have approved a new pain medication that even its manufacturers agree needs strict monitoring.

The medication is called Zohydro and one pill could kill a child. Two could cause an overdose in adults. Yet it is being put on the market weeks from now.

Zohydro is an opioid containing hydrocodone, a very common active ingredient in pain medications like Vicodin and Percocet. But Zohydro is different in that just one dose packs an especially powerful punch, up to 10 times that of standard opioids.

The makers of the drug, a company called Zogenix, have said that they believe their product is safe when used as prescribed. They plan on working with only certain doctors in the beginning, to make sure that the medication is being given to the right patients who are suffering from severe and chronic pain.

From a recent CNN article on the topic, Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, said in an e-mail, "We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids. In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market."

One of the problems with Zohydro is the level of its potency (far stronger than what's on the market right now). Another problem is that it can be crushed and snorted, which makes it appealing to some drug abusers for a strong and fast high. Snorting just a few lines could be deadly.

Worried that this could be another OxyContin (a highly abused pain medication with the nickname "hillbilly heroin") fiasco, doctors are trying to reverse FDA approval. Nearly thirty state attorneys, and members of congress are also vying for a reversal.

But the FDA have gone ahead and approved it, despite the FDA's own panel of advisors saying it should not receive approval. Approval came after a very strong push from its makers.

It has been mentioned that the research and development of a drug like this is so expensive that a non-approval could financially ruin a company. Money, perhaps, can drive a very hard bargain.

Pain pill addiction has become a serious issue in the United States. Known as "pill mills", they are run by unscrupulous doctors who have been doling out pain medications to people without proof of injury of pain, for cash.

"Patients" talk to a doctor or nurse briefly about their pain, and then receive a large dose of strong opioids and often become regulars to these pain clinics.

Congress moved quickly to pass a law to close down these clinics that were dispensing millions of prescriptions for patients who lived up to a thousand miles away.

In a previous article of mine about pill mills I reported, "...this law saw a whopping 97 percent fall in Oxycontin sales when comparing sales from the first half of 2010 to one year later. [Thirty-two] million prescriptions of Oxycontin were sold in the first half of 2010. This would be, on average, 64 million sales per year. The population of Florida is 18.5 million."

Four hundred clinics were quickly shut down with many more following since.

Many Americans suffer from severe and chronic pain for a variety of reasons. Pain medication is needed in plenty of cases but because of the addictive nature of these opioids and the high they can give, prescriptions need to be carefully monitored.

We can only hope that Zohydro does not end up being the nightmare that many doctors and addiction experts are warning about.


CNN.com. Health. "New pain pill's approval: 'Genuinely frightening'." Web. Retrieved Feb 27th, 2014.

EmpowHER.com. Addictions. "Florida's Pill Mills Finally Being Shut Down". Web. Retrieved Feb 27th, 2014.

Reviewed February 28, 2014
by Michele Blacksberg RN
Edited by Jody Smith

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.


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