The FDA’s own panel of experts did not believe Zohydro should enter the marketplace without tamper-resistant features. Normally a crush-proof coating would distribute the amount of medication throughout the body over an extended period of time, offering the patient relief around the clock. However, without the coating, people who want to abuse this medication can simply crush it and access the drug’s full potency. The effects are then both rapid and intense, putting the person at risk of an immediate fatal overdose.
The DEA reports that last year 4.5 million Americans abused opioid pain killers such as Percocet and Vicodin, both of which contain an opiate combined with acetaminophen. OxyContin, which does not contain either aspirin or acetaminophen, was reformulated a couple years ago with a coating that’s difficult to tamper with; the pill’s contents flake away if someone tries to crush and snort it. Some OxyContin formulations come with a polymer coating that simply turns to gel when crushed.
Zohydro’s manufacturer insists there is a documented need for an opiate analgesic without acetaminophen that will relieve discomfort around the clock for someone suffering from a painful injury or disease process. Nevertheless, the potential for Zohydro abuse is too dangerous when you consider expert opinion that this country is in the middle of an opiate addiction epidemic.
Temporary Ban on Zohydro
In Massachusetts, the governor has banned Zohydro prescriptions until Zogenix comes up with a formulation complete with a tamper-proof coating. In Vermont, several hospital administrators have stated that their hospitals will not stock the drug. Zogenix insists that its experts are guarding against the possibilities of Zohydro abuse, and the FDA reports that a new formulation containing a tamper-proof coating is in the early stages of development.
In the meantime, substance abuse officials and treatment professionals at rehab centers and methadone clinics are warning their patients away from this drug and its deadly potential for fatal misuse.