GRAND RAPIDS, Mich. (Feb. 26, 2014) — Before it even hits the market, a brand new painkiller has pharmacists, drug enforcement agencies, and state leaders scared about its potential for abuse and violence.
The company responsible for the drug said it could revolutionize care for those suffering from chronic pain.
Right now pharmacists said wholesalers are placing orders for a drug called Zohydro, said to be available by prescription only, in March.
It’s a painkiller, like Vicodin, only more potent and its potential for addiction has some worried that people will die from overdose or kill to get their hands on it.
One West Michigan pharmacist, Ken Fagerman, is particularly worried about what will happen when the drug becomes available to the masses.
“It’s coming on the market raw,” he said. “That quite frankly scares the heck out of us.”
Zohydro contains pure hydrocodone, the main pain killing ingredient found in Vicodin. Only Zohydro is available in higher doses.
“It’s ten time a typical starting strength of Vicodin and that is really a scary thing to have in a single capsule,” said Fagerman.
He’s not alone in that fear, 29 State Attorneys General, including Bill Schuette of Michigan, signed a letter addressed to the FDA. The letter urges the agency to keep this drug out of circulation.
“We are very fearful of this product and its release at this time,” he said.
The manufacturer is a company called Zogenix. Doctor Bradley Galer, the chief medical officer of Zogenix said it’s what the drug doesn’t contain that makes it unique.
A statement on the company’s website reads in part, “As the first and only extended-release hydrocodone without acetaminophen, we expect Zohydro ER to fill a critical need for people suffering from chronic pain.”
Fagerman explains, “Too much acetaminophen however is bad for your liver and kidneys.”
In 2012, an FDA panel voted against Zohydro in an 11 to 2 vote. This fall the FDA gave the drug approval. In an email to FOX 17 Morgan Liscinsky, an FDA spokesperson wrote, “Although advisory committees provide independent opinions and recommendations to FDA, their recommendations are not binding, and the agency makes the final decisions. FDA has concluded that the benefits of Zohydro ER outweigh its risks when used as provided in the approval labeling.”
The real concern for some in the unknown. Pharmacists have seen the potential for abuse and crimes committed to obtain potent painkillers. Some worry that a drug like this will take them down a dangerous path.
“There will be issues with this product without a doubt and violence probably associated with it,” said Fagerman.
An issue Fagerman wrote about in his book called Staring Down The Barrel: A Pharmacists Guide To Diversion and Coping with Robbery.
Fagerman said one of the most frightening aspects of this drug is the way the drug is coming to the market. Other drugs, like Oxycontin for example, have been reformulated to prevent abuse.
When crushed an Oxycontin pill and then attempt to melt it down for injection it turns into a gell.
Fagerman said it will likely be years before Zohydro is reformulated in that manner.