One of the most controversial drugs to come to market in many years, the new painkiller known as Zohydro ER (hydrocodone bitartrate) has set off alarms in the medical, law enforcement and drug rehabilitation communities nationwide.
The medication itself isn't new — it's hydrocodone, the opioid-based drug currently available as Vicodin (which also contains the pain reliever acetaminophen [Tylenol]). But it comes in a stronger dose: Zohydro is pure hydrocodone available as an extended-release formula in a highly potent capsule.
Twenty-eight different states' attorneys general have urged the FDA to withdraw their approval of Zohydro, and the FDA's own advisory panel voted 11 to two against approving the drug. So why is the agency allowing the drug to go on sale in March? [Aspirin to Zoloft: The Scoop on 5 Medicines]
'It will kill people'
An activist group protesting "the opioid epidemic" has demanded the FDA answer that question. "In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid," the members of Fed Up! wrote to the FDA in a letter dated Feb. 26.
"It will kill people as soon as it's released," Dr. Andrew Kolodny, a member of Fed Up!, told Forbes. "It's a whopping dose of hydrocodone packed in an easy-to-crush capsule."
Users could crush the Zohydro capsule, which can contain as much as 10 times the amount of hydrocodone as one Vicodin pill, into a powder and then snort or inject it, addiction experts worry.
"Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules," wrote the Fed Up! authors. "A single capsule could be fatal if swallowed by a child."
Opioid-related deaths rise
The Centers for Disease Control and Prevention (CDC) has noted an alarming increase in deaths related to opioid and other painkillers since the 1990s: According to the agency, 16,651 people in the United States died from using painkillers in 2010, compared to 4,030 deaths in 1999.
And these deaths are directly related to the sales of legal, prescription pain meds such as hydrocodone, oxycodone and methadone: "The unprecedented rise in overdose deaths in the U.S. parallels a 300-percent increase since 1999 in the sale of these strong painkillers," according to the CDC website.
Making Zohydro safer
Zoginex, the San Diego-based manufacturer of Zohydro, has stated its interest in preventing overdoses and misuse of the medication. The company claims that their drug is safer than painkillers that contain acetaminophen, which has been linked to liver problems.
"Zogenix is committed to promoting the appropriate use of Zohydro ER through a comprehensive suite of voluntary initiatives," including educational resources, surveillance programs and an abuse-deterrent formulation of the drug (which may include niacin or other compounds that make it undesirable to snort or inject the medication), according to a statement on the company's website.
But it remains to be seen if any of their steps will mollify critics of the medication.
"Zohydro ER has the potential to exacerbate the prescription pill epidemic," said Kentucky Attorney General Jack Conway, as quoted in the National Pain Report. "The FDA's decision to approve the drug doesn't make sense."