Doctors and addiction treatment groups are calling for the Food and Drug Administration to revoke its approval of a painkiller they say could be deadly and lead to another spike in opioid addiction.
The FDA approved the drug Zohydro in the fall, and it’s expected to be available to patients with chronic pain starting in March, according to CNN.
The pills contain a high dose of hydrocodone, a narcotic drug that has effects similar to heroin, according to an explainer in MedPage Today. Other hydrocodone painkillers, such as Vicodin, contain a dose five to 10 times lower than Zohydro and are combined with over-the-counter pain relievers like acetaminophen (Tylenol) or ibuprofen.
“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released,” Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, told CNN. He signed onto a letter submitted by dozens of health care, consumer, and addiction treatment groups asking the FDA to revoke its approval of the drug.
Zohydro is an extended-release pill with a high dose of hydrocodone that is supposed to be released slowly into the system over a 12-hour period. But since the pill packs so much hydrocodone, it could be appealing to addicts and opioid abusers looking for a quick and dramatic high that comes from crushing or chewing the pill to release all the hydrocodone at once.
Respiratory depression can happen when someone consumes too high a dose of a painkiller. It causes people to stop breathing and die.
Zohydro’s website acknowledges the dangers of the drug, saying it “exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death” if the patient’s pill regimen is not monitored closely.
Attorneys general in more than two dozen states have expressed concern that this drug could lead to a repeat of the past, when new painkillers entered the market without clear guidance on how they should be prescribed.
With the rise of opioid pain management over the past two decades has come a spike in addiction to both pain pills and heroin. Painkillers were the second-most abused drug in America in 2012, with 2.1 million people admitting to dependence or abuse that year, according to the Substance Abuse and Mental Health Services Administration.
Zogenix, the pharmaceutical company that makes the drug, sent us this statement about Zohydro: “Zogenix is fully engaged in implementing abuse deterrence initiatives, including developing an abuse deterrent formulation of Zohydro ER. We are currently evaluating two different technologies to ensure we develop the most effective formulation to minimize misuse and abuse.”
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