by Tony Isaacs
(The Best Years in Life) Over the objections of its own advisory panel, the FDA recently approved another killer drug which hit the pharmacy shelves earlier this year. The powerful new painkiller is named Zohydro and it is a whopping 10 times stronger than Vicodin. In approving the drug, the FDA ignored an overwhelming 11 to 2 vote against approval by the advisory panel and dire warnings and objections from state attorneys general and a coalition of health care, consumer and addiction treatment groups.
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Zohydro Set to Become the King of the Opiods
Zohydro is a super concentrated time-release opioid. Despite being packaged in time-released form, experts warn that the potential for abuse is huge, since the drug can easily be crushed and then either snorted or dissolved and injected.
The new drug belongs to a family of medicines known as opioids because they mimic the active ingredient found in the opium poppy plant. Others opioids include morphine, oxycodone, codeine and methadone.
Though it did not hit pharmacy shelves until March, the FDA actually approved Zohydro last October, making it the first single-ingredient hydrocodone drug ever cleared for U.S. patients. The pill uses an extended release formulation that is reportedly five to 10 times more potent than currently available hydrocodone combination pills, such as Vicodin. The approval surprised many doctors, coming after the FDA advisory panel voted overwhelmingly against the drug, citing its potential for abuse.
The FDA and San Diego-based Zogenix, who makes Zohydro, justified the drug by maintaining that it is needed to help patients who are unable to find enough relief from current medications. However, doctors and other experts have warned that the risks do not outweigh the benefits, noting that the new drug is so strong that only two capsules could be fatal for an adult and a single capsule could kill a child.
Objections to Approval of Zohydro
Attorneys general from 28 states plus the territory of Guam have written the FDA objecting to the new drug and a coalition of more than 40 health care, consumer and addiction treatment groups sent a letter to the FDA warning that the release of the drug will result in dire consequences.