FDA Approval of New Painkiller Sparks Controversy
A new painkiller approved by the FDA called Zohydro ER is sparking controversy in several states aiming to place restrictions on the drug, or ban it altogether.
Zohydro is an extended release formulation of the popular opiate painkiller hydrocodone. Because of the fact that the drug is meant to work over a long, 12-hour period, it is made in high doses, including a 50 milligram that is five times as powerful as the most potent instant release formulation.
Critics of the drug are incensed that the FDA would allow a new opiate onto the market just when painkiller addiction has risen to epidemic status in the United States. Over 38,000 of the drug overdoses in 2010 involved narcotic painkillers, and variations on hydrocodone, such as Norco and Vicodin. Zohydro even comes in a capsule form that can easily be crushed and snorted, a fact that has critics outraged given that many other extended release drugs are produced with special abuse-resistant characteristics.
But proponents of the drug are quick to point out that unlike other versions of hydrocodone and oxycodone (Percocet), Zohydro is formulated without acetaminophen, commonly referred to as Tylenol. According to Zogenix, Inc., the company behind Zohydro, acetaminophen overdose is the number one culprit of acute liver failure, and over 60 percent of all cases involving acetaminophen overdose are caused by hydrocodone/acetaminophen combo drugs.
The release of Zohydro has already prompted Massachusetts to institute strict regulations on the drug, requiring patients to sign risk assessment and pain management agreements. At the rate backlash against the drug is going, it may not be long before several other states follow suit.
Sources:
http://www.foxnews.com/health/2014/04/28/zohydro-why-this-new-painkiller-could-spark-new-addiction-epidemic/
http://well.blogs.nytimes.com/2014/04/21/new-painkiller-rekindles-addiction-concerns/
A new painkiller approved by the FDA called Zohydro ER is sparking controversy in several states aiming to place restrictions on the drug, or ban it altogether.
Zohydro is an extended release formulation of the popular opiate painkiller hydrocodone. Because of the fact that the drug is meant to work over a long, 12-hour period, it is made in high doses, including a 50 milligram that is five times as powerful as the most potent instant release formulation.
Critics of the drug are incensed that the FDA would allow a new opiate onto the market just when painkiller addiction has risen to epidemic status in the United States. Over 38,000 of the drug overdoses in 2010 involved narcotic painkillers, and variations on hydrocodone, such as Norco and Vicodin. Zohydro even comes in a capsule form that can easily be crushed and snorted, a fact that has critics outraged given that many other extended release drugs are produced with special abuse-resistant characteristics.
But proponents of the drug are quick to point out that unlike other versions of hydrocodone and oxycodone (Percocet), Zohydro is formulated without acetaminophen, commonly referred to as Tylenol. According to Zogenix, Inc., the company behind Zohydro, acetaminophen overdose is the number one culprit of acute liver failure, and over 60 percent of all cases involving acetaminophen overdose are caused by hydrocodone/acetaminophen combo drugs.
The release of Zohydro has already prompted Massachusetts to institute strict regulations on the drug, requiring patients to sign risk assessment and pain management agreements. At the rate backlash against the drug is going, it may not be long before several other states follow suit.
Sources:
http://www.foxnews.com/health/2014/04/28/zohydro-why-this-new-painkiller-could-spark-new-addiction-epidemic/
http://well.blogs.nytimes.com/2014/04/21/new-painkiller-rekindles-addiction-concerns/
The information supplied in this article is not to be considered as medical advice and is for educational purposes only.
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5 May 2014