More than 40 healthcare, consumer and addiction treatment groups are urging the Food and Drug Administration (FDA) to revoke approval of the prescription drug Zohydro.
The hydrocodone-based drug is the latest in a long line of painkillers called opioid analgesics. The FDA approved the medication last fall to treat chronic pain caused by work boots, and it is set to become available to patients in March.
“In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.
“Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”
There have been similar concerns about the drug. In December, a group of attorneys sent a similar letter to the FDA. In November, members of Congress impressed upon the agency to review their decision.
The main cause of concern from all groups is because of the drug’s potency and abuse potential. Zohydro, if taken at higher doses, is likely to amplify already-rising overdose numbers. A social website called change.org has a petition on its website terming the drug as the next OxyContin.
Figures from the Centers for Disease Control and Prevention highlight that prescription opioid deaths have quadrupled since 1999.
Maker of Zohydro, Zogenix and the FDA are of the opinion that the drug’s benefits outweigh its risks.
“We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids,” said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, in an e-mail. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”
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