A new medication made its debut on the mass market this March: Zohydro, a hydrocodone painkiller in an extended-released capsule.
While this may mean relief for those experiencing chronic pain, experts are cautioning the drug may kill people as soon as it starts being prescribed.
So much controversy and concern surrounds this drug that Massachusetts has imposed a temporary emergency ban on Zohydro, preventing it from being available anywhere in the state.
This is the first time any state has attempted to regulate an FDA-approved medication, but politicians stand by their decision, taking the case to federal court.
Why is there such dissent regarding Zohydro?
After all, hydrocodone has been available for years. According to Dr. Andrew Kolodny, a member of Fed Up!, a fatal overdose in an adult could occur just with taking two pills, and children would be even less likely to survive the medication, reaching overdose levels with a standard adult dose.
“It will kill people as soon as its released,” Kolodny told Forbes.
“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule.”
Painkiller deaths already number in the thousands annually, with more than 16,000 deaths attributed to painkillers in 2010.
What’s more, that count is only the individuals who obtained painkillers legally, through prescriptions, and it’s still 300 percent higher than painkiller deaths recorded back in 1999.
Now take into account the people who abuse painkillers as a form of addiction, who obtain them illegally, and you have the potential for a serious increase in hydrocodone mortality.
Even members of the FDA advisory panel on Zohydro acknowledged the abuse potential.
“If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products, wrote James Tolliver, a pharmacologist and medical officer at Lori Love, MD.
The new capsule contains five times the dose of standard hydrocodone medication, and though it has been designed to be extended release, Kolodny told WebMD it could easily be tampered with to release the entire dose all at once.
The FDA, however, approved the new medication for sale in March, despite heated controversy over the pros and cons.
“I firmly believe that the benefits of this product outweigh its risks,” the FDAs Bob Rappaport, MD, wrote in the summary review explaining why he approved Zohydro.
“”Many patients in the U.S. suffer from untreated or poorly treated chronic pain. Further limiting access to potential treatments is not the answer when new treatments are critically needed.
Kolodny and other experts disagree that there is a need for a medication like Zohydro on the market.
They recommend that instead of spending time and money to test such potentially dangerous drugs, more research be done into the field of pain management in general, to see how current drugs truly affect the body.
Currently there is little research supporting the use of opioids such as hydrocodone for non-cancer pain beyond a 3-month period.
Doctors should first be looking to combine physical, cognitive and current drug therapy as a form of pain management rather than simply seeking a “stronger” medication, argue experts.