FDA Responds to Criticism of Drug Critics Call 10 Times More Powerful Than Oxycontin

Zohydro is first pure form of hydrocodone, per FDA

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    NEWSLETTERS

    A prescription drug about to hit drugstores nationwide has lawmakers, doctors and police worried about its potential for abuse, despite the FDA's seal of approval. News4 I-Team's Tisha Thompson reports. (Published Wednesday, May 14, 2014)

    A prescription drug about to hit drugstores nationwide has lawmakers, doctors and police worried about its potential for abuse, despite the FDA's seal of approval.

    Zohydro is a type of hydrocodone -- the same opioid the Food and Drug Administration said is in Vicodin, Lortab and other painkillers often prescribed after surgery. Those drugs also contain acetaminophen, which in high doses can cause liver damage over time.

    The FDA said Zohydro is the first pure form of hydrocodone and is meant for patients with intense chronic pain like lupus and end-stage cancer. The drug was approved by the FDA, despite its advisory committe voting 11 to 2 against it.

    When the FDA first approved OxyContin in 1995, like Zohydro, it was crushable.

    “When you crush it, when you snort it, you are getting an instantaneous high,” Major Jason Bogue with Prince George’s County’s Narcotics Division said.

    Bogue said police departments nationwide are worried about what a Zohydro addiction could lead to.
    "What's out there that will give me the same euphoria and ease the pain? Heroin. Because I'm only paying $10 for a packet of heroin on the street instead of $80 a pill," Bogue explained.

    After OxyContin flooded the black market, its maker developed an "abuse deterrent formulation."

    "[OxyContin] can't be crushed into a powder so it can be easily snorted or ingested or even dissolved in water," Dr. Mike Carome with Public Citizen's Health Research Group told News4 I-Team.

    Zohydro critics, like Rep. Harold Rogers (R-KY), question why the FDA approved a drug so similar to OxyContin -- a legal but addictive opioid that launched what the FDA calls the nation’s prescription abuse “epidemic.”

    At a recent congressional hearing, Rogers said Zohydro "could be another OxyContin. Except this one is 10 times more powerful ... we're going to see more young people die."

    Public Citizen is one of 39 organizations and 29 states attorney's general asking the FDA to withdraw its approval of Zohydro.

    "The [FDA] should have waited until a tamper-resistant formulation was being developed," he said.

    According to Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, OxyContin is the only drug currently using abuse deterrent technology because it is expensive to develop and is protected by patent.

    "We understand the severity of the epidemic of abuse and death from overdose from opioids and that's a terrible problem,” Dr. Woodcock said. “We also understand the needs of patients for good pain medicines who are suffering."

    Woodcock said the FDA approved Zohydro in spite of all the opposition because the FDA also decided to put its strongest type of warning, called a "black box" label, on all hydrocodone products, warning doctors hydrocodone can cause addiction and death.

    “We don't see Zohydro having a very broad use, it's really a niche product," she explained.

    Before Zohydro was approved, its maker, Zogenixs, told the FDA it anticipated making only 90,000 prescriptions a year, according to documents obtained by News4 I-Team.

    After the drug received approval, Zogenixs claimed in a recent media interview "millions legitimately need” the drug.

    Zogenix did not respond to the News4 I-Team’s repeated requests for comment.  

    On the Zogenix website, a message reads: "Rampant misinformation about Zohydro continues to be reported” and “these inaccurate and misleading statements” are “intended to be sensational, to create fear.” The company says it “will continue to demand due process and fair treatment for our medications and our company."

    The stakes are high for Zogenix. In a government report, the company told its investors it is more than $30 million in debt and needs the drug to succeed or it will run out of money by the end of the year.