Approval of Opioid Painkiller Earns Outrage

A painkiller just approved by the Food and Drug Administration (FDA) is creating quite a stir among groups that oppose opioid prescription drugs.

The drug Zohydro is a hydrocodone-based drug that was approved last autumn for the treatment of chronic pain. With it set to become available to patients this March, groups set against the drug and drugs like it have begun calling for the FDA to reconsider its approval.

In a Change.org petition, the group known as The FED UP! Coalition has addressed Marget A Hamburg, M.D.. Commissioner of the U.S. FDA to stall Zohydro's release so that regulators can reconsider the drugs approval. The authors of the petition claim that Zohydro can be "the next OxyContin," a prescription painkiller commonly abused by opioid addicts in the U.S.

According to the petition, Zohydro contains approximately ten times more hydrocodone -- a powerful opioid that makes certain painkillers popular among drug abusers -- than prescription painkillers already available to U.S. citizens. The authors behind the petition are claiming that with such a high dosage per pill, it is possible that a person could suffer an overdose after taking just two capsules. In children, they claim even one could be fatal.

Dr. Andrew Kolondy, president of the advocacy group Physicians for Responsible Opioid Prescribing and an associate of The FED UP! Coalition told CNN today that because of Zohydro's massive dose-per-pill, he suspects people will die of overdose nearly immediately after it become available.

But the FDA and Zohydro's maker, Zogenix, claim that the drugs benefits outweigh the risks. The prescription painkiller will be the first of its kind that can address chronic levels of pain without the need for acetaminophen, a pain relief ingredient that can lead to overdoses that are almost always fatal. Even non-fatal overdoses have been found to lead to serious liver damage in patients. Zogenix asserts that while there are acetaminophen-free painkillers already in the U.S. market, none have the strength to treat chronic pain.

Still, the petition against Zohydro claims that this doesn't necessarily mean the drug is "safer." As an opioid, abuse of the drug appears to be inevitable. Opioid overdoses often cause asphyxiation, which can be just as fatal as an acetaminophen overdose.

According to the Centers for Disease Control and Prevention, deaths tied to prescription opioid deaths have more than quadrupled since 1999 with over 16,000 deaths in 2010. Still, it's not all bad news. The drug naloxone, an emergency treatment that saves the lives of opioid overdosers, is gaining traction in the Whitehouse. It may even soon become an option to provide this drug to the family and wards of known addicts to help save lives. It may be that the FDA considered this in their decision to approve Zohydro, as there is currently no emergency treatment for a potentially fatal acetaminophen overdose.

Regardless of the FDA's decision concerning the petition, The FED UP! Coalition will be staging a rally at the Nation's Capitol on September 28 to protest the FDA's lack of prescription opioid regulation.

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