The Food and Drug Administration has been criticized for approving a new painkiller called Zohydro. The drug is considered to be highly addicting.
A consortium of health professionals, law enforcement officials, and addiction specialists is calling on the Food and Drug Administration to stop a new drug called Zohydro due its risks.
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Zohydro, a painkiller, reportedly contains up to 10 times more hydrocodone, a semi-synthetic opioid. Although it does contain the liver-damaging Acetaminophen, it can be highly addicting. Furthermore, Zohydro does not have a tamper-resistant formula, making it easy to be crushed, snorted, and even injected.
Dr. Andrew Kolodny, a Phoenix House Chief Medical Officer, said that over 125,000 people in the U.S. have died from painkiller overdose in the past 10 years.
"This is a severe epidemic that is getting worse. The last thing we need is a new high-dose dangerous opioid to hit the market," Kolodny said.
Despite the scrutiny, the FDA has approved Zohydro in October last year, and it already scheduled to hit the market in March.
San Diego-based drug manufacturer, Zogenix, defended the reputation of the drug, saying that Zohydro is designed to handle pain "severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." Zogenix executives added that the drug is the first ever extended-release hydrocodone medication that does not contain Acetaminophen.
In a recent statement, the FDA declared that Zohydro's benefits outweigh the risks involved. But the agency has agreed to review the petition.