INDIANAPOLIS (WISH) – Zohydro has created controversy since it was approved last October by the FDA, and now, dozens of groups, one of which includes Indiana’s Attorney General, are urging the FDA to revoke approval of the hydrocodone-based drug.
“This will be a very popular drug for those people who have drug problems,” says Dr. Timothy Kelly, Medical Director of Fairbanks addiction treatment and recovery center in Indianapolis.
Dr. Kelly fears Zohydro will add to the epidemic of prescription drug abuse he sees daily.
“It has the potential to cause overdose, because it’s five to 10 times stronger than the usual hydrocodone,” says Dr. Kelly.
Zohydro, manufactured by Zogenix, is the first single ingredient hydrocodone drug set for release in the United States. The company says it’s an important tool in easing the pain of chronic sufferers who have not had any luck with drugs already on the market.
“It’s just a lot of hydrocodone in one pill. And my understanding is that it can be crushed and snorted and used in other ways that make it even more dangerous,” says Dr. Kelly.
Fear of that potential danger prompted a letter from Attorney Generals in 28 states, including Greg Zoeller of Indiana, urging the FDA to reconsider it’s approval of the drug or asking that it be reformulated with an abuse deterrent.
“It’s designed to be released slowly over a period of time. But if you snort it or find some other way to use it or inject it, then you take a whole dose in minutes instead of hours,” says Dr. Kelly.
And that, he says, has the potential for accidental overdose.
An FDA expert advisory panel voted 11-2 not to approve the drug, but the FDA approved it anyway.
“If the people who thought this drug was a great idea did my job for two or three days, they would have respect for the dangerousness of this drug,” says Dr. Kelly.
Zohydro is scheduled to hit the market with a doctor’s prescription this week. But Senator Joe Manchin of West Virginia is trying to get Health and Human Services Secretary Kathleen Sebelius to overrule the FDA’s decision to approve the drug.