Pregnancy, Babies, Parenting News & Tips

Cocerns raised over potency of FDA-approved Zohydro pain pill

By Jenna Iacurci / Feb 26, 2014 04:26 PM EST

Tags : addiction, Zohydro, pain, pill, medication, overdose, abuse

  • Concern over addictive Zohydro pain pill
  • (Photo : Flickr.Thirteen of Clubs) Health care, consumer and addiction treatment groups are concerned about the newly FDA-approved Zohydro pain pill.

Health care, consumer and addiction treatment groups are concerned about the newly FDA-approved Zohydro pain pill.

This coalition is urging the Food and Drug Administration to retract its approval of the prescription painkiller, classified under opioid analgesics, for fear of its potency and potential for abuse.

Like Us on Facebook

The medication was approved last fall to treat chronic pain and will be available to patients in March; however, that hasn't stopped concerned individuals from writing letters to the FDA asking the agency to take it off the market.

"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 groups wrote in a letter to FDA Commissioner Dr. Margaret Hamburg, reports CNN.

According to the Centers for Disease Control and Prevention, prescription opioid deaths have quadrupled since 1999 and these groups are worried that, based on its potency, Zohydro could contribute to this climb.

"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 who is not a part of the current petition. "I'm five times more concerned, solely based on potency."

The maker of the drug, Zogenix, believes that Zohydro's benefit outweighs its health concerns.

"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 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."

Galer added that the company would ensure only appropriate patients with chronic pain would receive the painkiller - those with low back pain, fibromyalgia, arthritis or other chronic conditions - if it's used like other opioids.

Meanwhile, the FDA has switched the drug to Schedule II (still pending approval by the Drug Enforcement Administration), meaning stricter dispensing and prescribing rules.

© 2014 All rights reserved. Do not reproduce without permission.
Featured Video : Never Leave Your Child Alone in the Car: Parents Urged to Take Heat Stroke Seriously Before it's too late

Many overweight children think they are thinner

Most children and teens who are overweight perceive themselves to be much thinner than they actually are, according to a new report from the Centers for Disease Control and Prevention.

Read More »

Obesity Linked to Low Endurance, Increased Fatigue in the Workplace

U.S. workplaces may need to consider innovative methods to prevent fatigue from developing in employees who are obese. Based on results from a new study published in the Journal of Occupational and Environmental Hygiene (JOEH), workers who are obese may have significantly shorter endurance times when performing workplace tasks, compared with their non-obese counterparts.

Read More »

Wide-Faced Men Negotiate Nearly $2,200 Larger Signing Bonus

Study finds men with wider face are successful when negotiating for themselves, but not so when the situation requires compromise and collaboration

Read More »

Schizophrenia has clear genetic ties, new DNA study suggests

In the largest study of its kind, researchers have learnt there are over 100 genes that play a role in the development of schizophrenia - one of the most common psychiatric disorders affecting people around the world.

Read More »

Preschoolers Can Reflect on What They Don’t Know

Contrary to previous assumptions, researchers find that preschoolers are able to gauge the strength of their memories and make decisions based on their self-assessments. The study findings are published in Psychological Science, a journal of the Association for Psychological Science.

Read More »

How children categorize living things

Linguistic, cultural forces shape children's understanding of the natural world

Read More »

Probiotics may help lover blood pressure: Study

A new study found that regular consumption of probiotics, or the "good" bacteria found in yogurt, milk and cheese, may help control blood pressure.

Read More »

Large twin study suggests that language delay due more to nature than nurture

Language traits analyzed in the study -- vocabulary, combining words and grammar -- were significantly heritable

Read More »

Missing sleep may hurt your memory

Lack of sleep, already considered a public health epidemic, can also lead to errors in memory, finds a new study by researchers at Michigan State University and the University of California, Irvine.

Read More »

Scripps Florida Scientists Identify Gene that Plays a Surprising Role in Combating Aging

It is something of an eternal question: Can we slow or even reverse the aging process? Even though genetic manipulations can, in fact, alter some cellular dynamics, little is known about the mechanisms of the aging process in living organisms.

Read More »

No evidence that California cellphone ban decreased accidents, says Colorado University Boulder researcher

In a recent study, a researcher at the University of Colorado Boulder found no evidence that a California ban on using hand-held cellphones while driving decreased the number of traffic accidents in the state in the first six months following the ban.

Read More »

New study finds one-third of Alzheimer's cases are preventable

Scientists have linked a new protein to Alzheimer's disease, different from the amyloid and tau that make up the sticky brain plaques and tangles long known to be its hallmarks.

Read More »

Real Time Analytics