AG Gansler Urges FDA to Reconsider Zohydro ER Decision
Highly addictive drug is focus of bipartisan effort of 28 Attorneys General
Baltimore, MD (December 12, 2013) - Attorney General Douglas F. Gansler, joined by a bipartisan group of 27 other attorneys general, today urged the commissioner of the U.S. Food and Drug Administration (FDA) to reconsider its recent decision to approve the high-dose narcotic painkiller Zohydro ER. In October, the FDA approved Zohydro ER against the recommendation of its advisory panel, which voted 11-2 in opposition because of the drug's high potential for misuse and its lack of an abuse-deterrent formulation.
"Prescription drug abuse is a serious and devastating issue for thousands of Maryland families," said Attorney General Gansler. "The approval of Zohydro ER is particularly troubling since this narcotic has no abuse-deterrent properties, unlike other extended-release painkillers available by prescription."
One day before approving Zohydro ER, the FDA recommended reclassifying all hydrocodone products to Schedule II controlled substances because of the abuse potential. Zohydro ER is the first hydrocodone-only opioid narcotic and is reported to be 5 to 10 times more potent than traditional hydrocodone products that are usually manufactured in a formulation with other non-narcotic analgesics.
Quoting from the Attorneys General letter to the FDA:
"State Attorneys General do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed. This created an environment whereby our nation witnessed a vicious cycle of overzealous 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."
To see the letter written to the commissioner of the FDA, visit: http://www.oag.state.md.us/Press/Zohydro.pdf
For more information on prescription drug abuse, visit the White House National Office of Drug Control Policy at http://www.whitehouse.gov/ondcp/prescription-drug-abuse