Zohydro: Do We Need It?
Allow me to “speak” candidly. I really have no idea why the FDA has approved the highly controversial painkiller Zohydro. Pain specialists and addiction treatment providers are overwhelming against its use, including the FDA’s own research and development specialists. Why does the FDA ask for the opinions of science professionals if that advice is completely disregarded?
The agency approved Zohydro last year over the objections of its own staff and advisory committee, which warned the painkiller could be abused even more than currently available hydrocodone products.
Many addiction treatment specialists are concerned with the available high dosage, high for immediate-release hydrocodone pills. Even though the formulation is meant to release hydrocodone slowly over 12 hours, the pill could be tampered with to release a large dose all at once. Compounding the problem is that the pills can be crushed and abused by I.V. drug addicts. The FDA could have insisted on the creation of and abuse-deterrent formulation of Zohydro before approval and distribution; doing so would have helped reduce the number of critics.
Opioid drug use is rising in America and prescription drug deaths are tragically occurring in huge numbers across the country. While there are some patients who may benefit from Zohydro, this has not been proven, and there are drugs and combinations of therapies available that give near identical results. Public safety should be foremost in any new drug approval process.
I am not sure why there was a great rush to put this drug on the market before a harder to abuse version with effective dosage adjustments was designed and tested. Zohydro does not meet the standard for a “new” drug that does something other drugs cannot. Its importance from a health perspective is murky at best. Certainly it is important to look beyond a single drug for answers to the prescription drug abuse epidemic, but why add fuel to the fire?