How can the federal Food and Drug Administration be so tone-deaf and dismissive of its own outside scientific advisory panel to let loose a powerful prescription painkiller that is pure, highly addictive hydrocodone?
Many people have been left wondering as they lobby the FDA to reverse this wrong decision. Zohydro provides 12-hour pain relief, but is subject to abuse. The drug is an extended time-release capsule of hydrocodone without the familiar additive of aspirin or acetaminophen. It will be available in pharmacies in the next couple of weeks. That’s unfortunate.
Local addiction treatment experts and families who have lost loved ones to overdoses have come out strongly against Zohydro.
The manufacturer, Zogenix, and the FDA say that the drug, which is a synthetic opiate, is safe if used correctly. The company says the drug is a necessary alternative for patients who have developed a tolerance to other painkilling opioids or can’t tolerate opioids mixed with other medicines.
While that may be true, the prospects of misuse outweigh its benefits. Zohydro’s heavy dose of hydrocodone will make it even more attractive to abusers, who will be able to crush the capsules and use the powder to create an intense, immediate high.
This has translated into real concern from law enforcement and others trying to fight the abuse of pain pills. Heartfelt pleas have gone out from people like Avi Israel, a North Buffalo resident whose son, Michael, committed suicide in 2011 after struggling with an addiction to prescription painkillers.
Sen. Charles E. Schumer, D-N.Y., urged the U.S. Department of Health and Human Services to overturn what he called the FDA’s “disastrous” decision to allow an ultra-powerful drug to enter the market in a form that can easily be abused. Other forms of these powerful painkillers have been reformulated so they can’t be crushed. Schumer wants the drug pulled until it can be made tamper-resistant.
The increase in addiction to painkillers was outlined in The News’ groundbreaking 2011 series “Rx for Danger,” about the meteoric rise in the abuse of painkillers and their prevalence in Western New York. That reporting helped lead the State Legislature to pass laws providing for electronic monitoring of prescription drugs.
This state and others are now also fighting the increase in heroin abuse, which is a less expensive alternative to the $30-per-pill painkillers. The extra dose of hydrocodone in the new pills will make Zohydro even more attractive to abusers.
The FDA should reverse its decision and immediately pull the plug on this new form of a potent painkiller, at least until it can be made tamper-resistant.