Citizen’s groups, doctors, and legislators question why the Food and Drug Administration approved a new prescription painkiller called Zohydro, which carries a dire black box warning of “Life-threatening respiratory depression, addiction, interaction with alcohol,” and other serious risks.
The warning label says a single dose could kill a child.
If pregnant women take it, their newborns could die from opioid withdrawal, according to the manufacturer’s warning.
Approved in October 2013, it is not yet available. It goes on sale in March.
It will be 5 to 10 times stronger than Vicodin.
First and Only
Zohydro is meant for people with severe pain that does not respond to other painkillers. It will be the “first and only extended-release hydrocodone available for pain, in an acetaminophen-free formulation,” according to its manufacturer, Zogenix. It is an opioid, from the same family as morphine, heroin, and oxycodone. Its warning says that even if used as directed, it can lead to addiction, abuse, and overdose, yet it is meant for people with chronic pain. The FDA warning says it must be prescribed with no refills, which seems odd if the pain is chronic.
“People will die if Zohydro becomes available,” wrote Dr. Michael Carome, director of Health Research for Public Citizen.
Last Thing the Country Needs
Carome signed an open letter to FDA Commissioner Dr. Margaret Hamburg. “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,” reads the letter, sent by the Fed Up Coalition on Feb. 26.
The coalition letter states that if the FDA approved the drug based on existing policies, then the policies urgently need revision. It asks the FDA to put public health before industry interests.
The United States has about 5 percent of the world’s people, yet it consumes 84 percent of the world’s oxycodone and 99 percent of the world’s hydrocodone, according to the letter.
Since 1999, opioid painkiller overdose deaths have increased by 415 percent for women and by 265 percent for men, the Centers for Disease Control reported.
Those who signed the letter include Carome, Dr. G. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness; Dr. Richard Falzone, instructor, Harvard Medical School, and 37 others.
Republican Sens. Mitch McConnell of Kentucky, Tom Coburn of Oklahoma, and Lamar Alexander of Tennessee sent a letter to Hamburg two weeks ago criticizing the FDA for approving Zohydro. Their letter says, “We believe the approval of pure hydrocodone products without methods to prevent abuse, misuse, and diversion, including abuse-deterrent formulations, poses a significant danger to our constituents, as it could worsen the drug abuse epidemic in our country.”
The FDA did not respond to a call by press time.
*Doctor image from www.shutterstock.com