Drugs/Therapy

FDA Approves Powerful Painkiller

By Cheri Cheng | Update Date: Oct 26, 2013 11:46 AM EDT

The U.S. Food and Drug Administration (FDA) recently announced that it plans on reclassifying prescription painkillers that have hydrocodone. Due to the risk of addiction, the FDA wants these types of painkillers, such as Vicadin, to fall under "Schedule II" medications, which would increase the regulation of these drugs. Despite trying to control prescription drugs with hydrocodone in a more efficient way, the FDA has also approved a pure hydrocodone drug known as Zohydro ER.

According to the FDA, Zohydro ER manufactured by Zogenix should be prescribed to people when all other options have failed. The drug is intended for "daily, around-the-clock, long-term treatment" and can only be used alone. The drug is the first ever pure hydrocodone drug to be approved in the U.S, and experts are critical of the FDA's approval.

Just last year, the FDA had reviewed Zohydro ER and gave it negative ratings. The agency had voted 11-2 against the approval of the drug since hydrocodone is one of the ingredients that get abused too often. Despite the dangers associated with hydrocodone drugs, in 2011, government data revealed that over 131 million prescriptions for hydrocodone were written out by doctors.

"FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous," Democratic Representative Bill Keating said in a statement reported by Medical Xpress. "Abuse-deterrent technologies should not be the anomaly, they must be the norm."

Avi Israel, the founder of Save the Michaels of the World, added, "We're just going to kill more kids and then the FDA is going to come back and say, 'oh, we made a mistake.'" Israel lost his son in 2011 due to painkiller addiction.

Hydrocodone is part of the family of medicines known as opiates or opioids. These types of medications are chemically similar to opium, which is highly addictive.

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