Zohydro FDA Approval Sparks Concerns From Several Groups
February 26, 2014

Group Calling For FDA To Revoke Pain Killer Approval

Lee Rannals for redOrbit.com - Your Universe Online

A group of 40 organizations have joined together to try and influence the Food and Drug Administration (FDA) to revoke its approval of the prescription drug Zohydro.

The group of health care professionals and consumer and addiction treatment groups say they are “echoing the concerns” of members of Congress and the State Attorneys General regarding the FDA’s decision to approve Zohydro for use.

“On behalf of consumer safety organizations, health care agencies, addiction treatment providers, community-based drug and alcohol prevention programs, professional organizations, and other groups on the front-line of our nation’s opioid addiction epidemic, we ask you to put the public’s health ahead of industry interests,” the group wrote in the letter. “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 organizations said if the FDA’s decision to approve the painkiller was based on existing policies, then those policies need “urgent revision.” The group is essentially pointing to the growing problems of prescription drug abuse in the country, where thousands of lives have been lost from overdose and hundreds of thousands of people have become addicted.

“Over the past 15 years, prescriptions for opioids have skyrocketed,” the letter read. “We implore you to take these painful lessons into account.”

According to the organizations, the US consumes more than 84 percent of the world’s entire oxycodone supply and more than 99 percent of the world’s hydrocodone supply, despite being only about 5 percent of the Earth’s population. The CDC says that the increase in prescription drug use has led to increases in addiction and overdose deaths.

“Since 1999, overdose deaths have skyrocketed, especially among middle-aged individuals prescribed opioids for chronic pain,” the group wrote. ”Opioid analgesic overdose deaths have increased by 415% in women and 265% in men.”

According to the group, Zohydro’s maker, Zogenix, said the drug is safer than existing hydrocodone products because it does not contain acetaminophen. However, the authors say the drug is not safe because it contains 5 to 10 times more hydrocodone than Vicodin or Lortab.

“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,” the group said.

They point out that patients who may be unable to take painkillers with acetaminophen already have alternatives.

“There is no need for another high-dose, single-entity opioid,” the group said. “Too many people have already become addicted to similar opioid medications and too many lives have been lost. We urge you to exercise your authority and responsibility to protect the public’s health by keeping Zohydro off the market.”

Despite the group’s claim, Zogenix says that the drug’s benefits outweigh the risks. Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, told CNN in an email that they do not believe the drug will increase the overall use of opioids. He also said they will be focusing its marketing on doctors with good experience prescribing opioids so only appropriate patients would receive the drug.