Opposition to Zohydro, the powerful new opiate some critics are calling “heroin in a pill,” continues to build, but the U.S. Food and Drug Administration is strongly defending the agency’s approval of the drug, saying its benefits to pain patients outweigh the potential negative consequences.
Since its approval by the FDA last October, Zohydro has come under fire from members of Congress, state attorneys general, doctors and addiction specialists who have worked to block the pill from being sold in the U.S., according to this article. Critics want the agency to rescind its approval of Zohydro, citing the alleged danger of the drug as well as the growing abuse of prescription drugs nationwide, but the FDA says that instead of blocking the sale of Zohydro based on a fear of abuse and addiction, providers should screen patients before they prescribe the drug and while they are on it, the article says.
The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, citing concerns about the danger of addiction posed by the opioid drug class.
In Massachusetts, Gov. Deval Patrick issued a ban on Zohydro in March, declaring a public health emergency in response to the state’s growing opioid addiction epidemic. But in April, a federal judge struck down the ban, saying the state lacked the authority to override the FDA’s approval of the painkiller.
Unlike other hydrocodone-containing drugs like Vicodin, Lortab and Norco, Zohydro is not buffered with acetaminophen or some other over-the-counter medication. The drug also lacks an abuse-deterrent feature such as the ones used in new formulations of drugs like OxyContin.
Hydrocodone consistently ranks as one of the most popular drugs among Americans who abuse prescription painkillers.
Zohydro’s maker, Zogenix, has said it will introduce a non-crushable version of Zohydro in three years and plans to closely monitor prescription abuse, claiming that millions legitimately need the drug.