Twenty-nine Attorney Generals signed a letter dated December 10, 2013 addressed to the Commissioner of the Food and Drug Administration. They urge the FDA to reconsider the approval of Zohydro. I have expressed my thoughts on this in two recent blogs More Powerful Opiods Approved (11.13.13) and Zohydro and Closed Formularies (12.09.13).
More than half of the country's chief legal officials are concerned about the approval of this new and very powerful painkiller. They note:
"This drug will be the first hydrocodone-only opiod narcotic"
This drug "is reportedly five to ten times more potent than traditional hydrocodone products."
This drug "has no abuse-deterrent properties."
The Attorney Generals remind the FDA of the toll that "potent painkilling drugs" have had. They note that there was
"an environment whereby our nation witnessed a vicious cycle ofoverzealous pharmaceutical sales, doctors over-prescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives."
On behalf of law enforcement, public health workers and substance abuse treatment providers, the Attorney Generals ask the FDA to reconsider the Zohydro approval or to set a "rigorous timeline for Zohydro" to be reformulated with "abuse deterrent" elements included.
There it is, in a nutshell. Painkillers are killing Americans. An American today is more likely to die from drugs than automobile accident.
The FDA has approved a significantly more powerful (5-10 times) version of hydrocodone with no anti-abuse properties. Is the FDA there to make American's safer? Will there be some sort of explanation as to why the FDA approved this drug over the objections of its own experts? Will the FDA provide some explanation or response to the Attorney Generals of 29 jurisdictions?
Signatories: Alaska * Arizona * Arkansas * Connecticut * Delaware * Florida * Georgia * Guam * Hawaii * Illinois * Indiana * Iowa * Kentucky * Maine * Maryland * Massachusetts * Michigan * Mississippi * Nevada * New Hampshire * North Carolina * Oregon * Pennsylvania * Rhode Island * South Dakota * Tennessee * Utah * Vermont * Washington
