New Painkiller Release Has Law Enforcement and Medical Experts Worried
The new release of the powerful painkiller Zohydro ER has both law enforcement and medical experts worried because of its properties.
Law enforcement and medical experts say that the release of the drug will only exacerbate ongoing prescription drug and heroin abuse problems.
About Zohydro ER
“I can see no medical advantage for allowing this drug on the market. And I can see enormous opportunities for injury to my patients and my neighbors…People who are addicted to these drugs will obtain these drugs, crush them up and snort them.” – Dr. Gilbert Fanciullo, director of pain medicine at Dartmouth-Hitchcock Medical Center as published by the New Hampshire Union Leader
Zohydro ER, is a time release form of hydrocodone and will be available is dosages as high as 50mg, posing a potential threat for abuse, overdose and death.
The FDA approved the drug and it is expected to hit the market next month. New Hampshire’s Attorney General Joseph Foster says that prescription opiates continue to pose a big problem, and that addicts usually switch from heroin when they can no longer get their hands onto painkillers legally.
According to the FDA, Zohydro ER meets the regulatory requirements and the product's benefits outweigh its risks when used as intended.
In September the FDA began requiring that all opioid painkillers include a black box warning label advising patients of serious adverse events, including addiction, overdose and birth defects.
Attorney General Calls for Strict Regulation of Zohydro
According ot the New Hampshire Union Leader, the Attorney General asked the FDA to reconsider their approval of Zohydro ER or to set a more “rigorous” timeline for the drug to be reformulated to be abuse deterrent, and he also asked the FDA to work with other federal agencies to impose restrictions on how the drug can be marketed and prescribed.
In response to that request, Zohydro ER was approved as a Schedule II controlled substance, which means that it can only be dispensed with a written prescription, it cannot be called into a pharmacy and no refills are permitted.
There are currently no hydrocodone products with “meaningful” abuse deterrent properties, but the FDA promises to “do what they can” to support Zogenix, who manufactures the drug, in developing such a formula for Zohydro ER.
Meanwhile, questions are arising about how the drug was approved. The FDA’s press officer Morgan Liscinsky said that agency officials are “currently unaware of any improperties” involving what they called “pay to play” meetings between drug manufacturers and the FDA officials who regulate them.