Despite Abuse Concerns – FDA Approved Drug

Approvals of medications by the US Food and Drug Administration are not usually lightning rods for controversy, but the recent approval of the painkiller Zohydro is drawing significant criticism. Critics of the new drug, a high-strength opioid manufactured by Zogenix Inc, have raised concerns about the potential for abuse associated with Zohydro, though FDA Commissioner Margaret Hamburg argued that the benefits of Zohydro significantly outweigh the potential drawbacks.

According to Hamburg’s remarks at a Senate Hearing Thursday, Zohydro meets the relevant standards for safety and effectiveness, and also fills a “unique niche” in terms of addressing serious pain. Hamburg conceded that it would have to be used in an appropriate manner in order to avoid potential harm, but that did not do much to stem the tide of criticism. Following the approval of Zohydro, the attorneys general of 28 states protested the move, and various medical organizations also voiced concerns over the potential for addiction problems.

A frequent concern voiced by critics is that Zohydro’s market presence and use might trigger a repeat of the widespread addiction issues associated with the original release of OxyContin. In addition to making their concerns heard, critics of the Zohydro approval have also petitioned the FDA to reconsider its approval and prevent the drug from being marketed, at least for the time being.

The approval of Zohydro was significant in that the FDA rejected the ruling of its panel of outside advisors, who suggested the drug was not safe enough to be put on the market, particularly given its lack of anti-abuse mechanisms. This concern was echoed at the Senate hearing, where members of the Senate Health, Education, Labor and Pensions Committee noted that Zohydro was not made in a way that would deter chewing or crushing the drugs in order to abuse them.

One of the staunchest critics thus far has been West Virginia Senator Joe Manchin, who called on Kathleen Sebelius, the Secretary of the Department of Health and Human Services, to overrule the FDA’s decision to approve Zohydro.

However, Hamburg defended the FDA’s decision by noting that responsible prescription practices by doctors and the drug’s lack of acetaminophen, which can have toxic effects on the liver, made the drug a safe product for prescription use.