A new painkiller approved by the Food and Drug Administration is scheduled to be available to patients next month — but it seems not without a fight. Opponents of the pill call its potency frightening and say it will begin killing people as soon as it's released.
"Over 40 health care consumer and addiction treatment groups want the FDA to revoke its approval of Zohydo, a hydrocodone-based drug. Zohydro was approved for treating chronic pain, but the coalition is concerned about the drug's potency and abuse potential." (Via WWLP)
A petition on Change.org calls Zohydro "the next OxyContin."
And Wednesday the Fed Up! Coalition wrote a letter to FDA Commissioner Margaret Hamburg saying, "In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid."
And in December members of Congress sent a similar letter to the FDA, asking for the decision to be reviewed. (Via U.S. Congress)
But CNN has a statement from the executive vice president and chief medical officer at Zogenix, the maker of Zohydro, who argues the benefits outweigh the risks.
"We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids. ... In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market."
Last October the FDA upgraded hydrocodone-containing drugs from a Schedule 3 to Schedule 2 controlled substance, "which would increase the controls on these products." Schedule 1 are drugs considered to have the highest potential for abuse.
The change could be one reason the FDA is confident Zohydro will not contribute to the so-called epidemic. (Via KSHB)
Zohydro's label will feature warnings about abuse, misuse and addiction. The drug's makers are reportedly working on an abuse-resistant version expected to be released in the next few years.