Addiction experts, physicians and more than 40 other health care officials, are urging the Food and Drug Administration to revoke approval of the prescription drug Zohydro.
The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.
The opioid drug contains a potent amount of an active ingredient that could be lethal to new patients and children and is not safer than other current pain drugs, the groups told the Food and Drug Administration.
“Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child,” they wrote in a petition to FDA Commissioner Margaret Hamburg, dated Wednesday.
“You’re talking about a drug that’s somewhere in the neighborhood of five times more potent than what we’re dealing with now,” said Dr. Stephen Anderson, a Washington emergency room physician. “I’m five times more concerned, solely based on potency.”
“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.”
“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” added Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.”
The same concerns are seen by the entire coalition group, mostly about the drug’s potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will increase already-rising overdose numbers.
Zohydro can contain as much as 10 times the amount of the narcotic hydrocodone as other painkillers such as AbbVie Inc’s Vicodin or UCB Inc’s Lortab, advocates said in their petition.
“Zohydro is not safer,” they wrote.
“This could be the next OxyContin,” says a petition on Change.org asking the FDA to reconsider the approval.
According to the Centers for Disease Control and Prevention, prescription opioid deaths more than quadrupled since 1999 — there were 4,030 deaths involving the drugs in 1999, compared with 16,651 in 2010.
Both Zohydro’s maker, Zogenix, and the FDA believe 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 to CNN. “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.”
Anti-addiction groups push FDA to revoke approval of Zohydro
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