A powerful painkiller called Zohydro, which was approved by the U.S. Food and Drug Administration (FDA) last fall for the treatment of chronic pain, is being called “genuinely frightening” by groups who oppose it.
This past week over 40 consumer watchdog and addiction treatment groups, as well as dozens of experts and healthcare agencies, all banded together to send a petition to the FDA asking that the hydrocodone-based drug’s approval be revoked.
The petitioners note that even the FDA’s own advisory committee put up significant resistance to the approval of the drug, voting 11-2 against allowing its sale.
According to the group, the country is in the middle of a severe epidemic of drug abuse which has been fueled by the overprescribing of opioid medications. The last thing we need, they say, is to add yet another powerful painkiller to the mix. Too many people have become addicted and even died, the group says.
One consumer group, Public Citizen, explains just how powerful Zohydro is by noting that even a single dose could kill a child.
A doctor who was involved with the petition, Dr. Stephen Anderson, says his concern with the pill arises from the fact that its potency is five times greater than currently available drugs.
Although representatives for Zogenix say the types of patients who might use the drug are those with chronic pain, Anderson believes that this is simply a ploy to get the drug on the market. Once it’s out there, he believes, the patient group will expand to other types of patients. It takes a great deal of money to develop a new drug, he says, and the drug manufacturer has a vested interest in recouping the money spent. Anderson believes that this will lead to the drug being prescribed to more and more patients, a prospect which he says he is “terrified of.”
Another expert, Dr. Andrew Kolodny, who is president of Physicians for Responsible Opioid Prescribing, says the drug’s capsule is also easy to crush, making it very easy to abuse.
On the other hand, both the FDA and the manufacturer of Zohydro, Zogenix, claim that the benefits to be gained from the drug outweigh any associated risks.
In addition, those who advocate for patients with pain issues state that, while addiction is a valid issue to consider, it is not such an important issue with pain patients. Paul Gileno, president of U.S. Pain Foundation, says that people who are suffering simply want to get relief so they can lead a normal life.
The drug was approved in October of last year and is due to become available for sale in March 2014. Unlike other currently available painkillers, Zyhydro a single-ingredient pill. Other drugs, such as Vicodin, are combination of painkillers.
No warnings will be present on the drug regarding its potential for abuse. However, Zogenix does say that an abuse-deterrent version of Zohydro could become available in three years’ time, hopefully alleviating some concerns about how frightening the drug is.
By Nancy Schimelpfening