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FDA approves more potent painkiller

Teresa Tanoos's picture
FDA approves powerful new painkiller called Zohydro ER.

The Food and Drug Administration (FDA) has approved a more powerful, extended-relief version of the painkiller hydrocodone, a prescription drug used to treat chronic pain, which is also known as a highly addictive and widely abused medication.

The FDA today approved the first extended-release "single ingredient" hydrocodone product, Zohydro ER, for treating patients suffering from pain so severe that they require continuous doses on a daily basis.

In December of 2012, an FDA panel of advisers gave a very negative report on Zohydro, voting 11 to 2 not to approve the medication last year.

The panel also questioned the need for a new version of a painkiller already known to be highly addictive and one of the most abused prescription pain medications in the nation.

The announcement by the agency to approve the stronger pain pill comes as a surprise, especially since the FDA announced just the day before that it would be recommending tighter controls for painkillers with hydrocodone, such as Vicodin.

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Yesterday’s announcement by the agency specifically targets combination pills that contain hydrocodone, also called opioids, which combine hydrocodone with weaker painkillers like acetaminophen.

These opioids are currently labeled as Schedule III medications, but if the FDA’s recommendation for stronger controls is accepted, the painkillers would be labeled as Schedule II drugs.

This would make it more difficult to get the drugs because a written prescription from a doctor, instead of a prescription taken over the phone, would be required in order to get the drugs filled. And to get a refill, the patient would have to see the doctor for a check-up before another prescription would be written.

While pure hydrocodone is already a Schedule II drug, re-classifying combination drugs with hydrocodone, such as Vicodin, would also put manufacturing quotas in place for these combo painkillers.

The Drug Enforcement Administration (DEA) categorizes prescription medications into one of five "schedules", depending on "whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential and their likelihood of causing dependence when abused."

Other drugs, including Adderall and morphine, are also labeled as Schedule II medications.

SOURCE: The Food and Drug Administration, News Release: FDA approves extended-release, single-entity hydrocodone product, October 25, 2013