More than 40 advocacy groups signed a letter to FDA Commissioner Margaret Hamburg asking the administration to reconsider the approval of the controversial drug Zohyrdro
As we’ve previously discussed, Zohyrdro is a hydrocodone packed painkiller 5 to 10 times as potent as Vicodin or Lortab. Researchers believe the drug is so potent that it can cause serious or even fatal reactions if consumed by children.
What makes this case odd is that the FDA approved Zohyrdro against the advice of it’s own advisory committee. Last October, the FDA’s advisory panel voted 11-2 against the approval of the drug, yet the administration made the recent decision to approve it. Unless something changes, Zohyrdro will be available later this month.
“I’m amazed that the FDA would approve a dangerous new opioid over the strong objection of its advisory panel,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “In the midst of a severe epidemic of opioid addiction and overdose deaths, this is the last thing we need.”
Preventing Misuse
Last month, three U.S. senators asked the FDA to explain how the administration will monitor and prevent abuse of the new drug. The FDA responded by re-classifying Zohydro as a schedule II drug, meaning it has stricter prescription constraints and higher penalties for illegal possession or distribution, but the administration still plans to let the drug hit the market.
Needless to say, many adults who have seen the troubling effects of painkillers believe the drug will only lead to more problems.
“I’m worried about their plan to market the drug for back pain and other common problems,” said Judy Rummler, chair of the FED UP! Coalition and president of the Steve Rummler Hope Foundation. Her son Steve died in 2011 when he overdosed on pain pills he was taking to control his chronic back pain.
“The capsules will contain a whopping dose of hydrocodone,” said Pete Jackson, who lost his daughter to an OxyContin overdose. “It’s crazy to let this drug go on the market as it undoubtedly will become the next OxyContin that will fuel the opioid addiction epidemic.”
While these parents may be a little biased based on the tragedies they’ve had in their lives, there’s little doubt that opioid abuse is rampant in America. According to the latest statistics, the United States is home to just 5 percent of the world’s population, but the nation consumes more than 99 percent of the world’s hydrocodone. It’s no surprise that addiction and overdose rates have grown over the past decade.
“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 group said in its letter to Hamburg.
Dr. Silverman comments
I’m still amazed the FDA decided to go against the advice of THEIR OWN ADVOCACY GROUP! It’s not like it was an outside recommendation, it came directly from the administration.
The FDA was first developed to protect the public, but this decision will clearly cause more problems than it will prevent. Unfortunately, it won’t be long before we see the headline, “Teen Dies From Accidental Zohydro Overdose.” It’s not a matter of if, but a matter of when.
You won’t find me ever writing a prescription for Zohydro.
Related sources: MedPage Today, Citizen.org