Groups Push FDA to Revoke Approval of Highly Potent Painkiller

By on February 26, 2014

Groups Push FDA to Revoke Approval of Highly Potent Painkiller

Dozens of experts and health care agencies sent a letter this week urging that the U.S. Food and Drug Administration revoke its approval of the supercharged painkiller, Zohydro.

In the petition sent to the FDA on Wednesday, more than 40 consumer watchdog groups, addiction treatment groups and others noted that the drug was approved despite significant resistance from the FDA’s own advisory committee, which voted 11-2 against allowing Zohydro to be sold.

According to consumer advocate group Public Citizen, which issued its own news release on the issue Wednesday, a single dose of Zohydro could kill a child.

The petition to the FDA warns that the painkiller is simply too dangerous and there’s no need for another high-dose opioid (prescription narcotic) painkiller.

“I’m amazed that the FDA would approve a dangerous new [medicine] over the strong objection of its advisory panel,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in the group’s news release. “In the midst of a severe epidemic of opioid addiction and overdose deaths, this is the last thing we need.”

Still, the FDA approved the drug, made by pharmaceutical companies Zogenix and Alkermes, in October despite negative feedback from its advisory committee, Public Citizen said.

Unlike other prescription painkillers such as Vicodin, which combine hydrocodone and acetaminophen, Zohydro is the first single-ingredient hydrocodone drug ever approved, Public Citizen said. It is scheduled to be available for sale in March.

Earlier this month, three U.S. senators also voiced concern about this new painkiller, asking the FDA to describe how it planned to prevent the abuse of this supercharged drug.

“Too many people have already become addicted to similar opioid medications and too many lives have been lost,” Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said in the Public Citizen news release. “The FDA should exercise its responsibility to protect the public’s health by reversing its approval of Zohydro.”

However, Zohydro has its proponents, too, including advocates for patients facing pain issues.

“We know that a person with pain is not a person who abuses medications,” Paul Gileno, founder and president of the U.S. Pain Foundation, which receives some pharmaceutical industry funding, told CNN. “A person with pain is a person suffering to get pain relief in order to live a fulfilling life,” he said.

One company behind the drug defended its introduction to the marketplace.

“We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids,” Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, told 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.”

He said Zogenix will target sales of Zohydro to a select group of physicians who have good experience prescribing prescription narcotics, so that only an appropriate group of patients in chronic pain get the drug.

That didn’t ease the fears of those opposed to the medication’s introduction, however.

“I’m worried about their plan to market the drug for back pain and other common problems,” noted Judy Rummler, chair of the FED UP! Coalition and president of the Steve Rummler Hope Foundation, in the Public Citizen news release. Rummler experienced the devastating effects of prescription drug abuse in her own family. Her son died of a drug overdose in 2011 after battling an addiction to painkillers prescribed for chronic back pain.

Prescriptions for narcotic painkillers have soared in the United States in recent years, and so have rates of addiction to the drugs. Although the country comprises just 5 percent of the world’s population, Americans consume more than 99 percent of the global supply of hydrocodone, Public Citizen points out.

“The [Zohydro] capsules will contain a whopping dose of hydrocodone,” Pete Jackson, president of Advocates for the Reform of Prescription Opioids, said in the news release. “It’s crazy to let this drug go on the market as it undoubtedly will become the next OxyContin that will fuel the opioid addiction epidemic.” Jackson’s daughter died after taking just one dose of the prescription painkiller OxyContin.

More information

The U.S. National Institute on Drug Abuse provides more information on prescription drug abuse and addiction.

Source: HealthDay

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