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 ParentHerald.com 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

Johnson & Johnson pulls controversial hysterectomy tool from market

Johnson & Johnson is withdrawing from the global market a device used during hysterectomies and other uterine procedures after reports that it may spread and accelerate the growth of undetected cancer inside women.

Read More »

Fear of Losing Money, Not Spending Habits, Affects Investor Risk Tolerance

As the U.S. economy slowly recovers, many investors remain wary about investing in the stock market. Investors' "risk tolerance," or their willingness to take risks, is an important factor for investors deciding whether, and how much, to invest in the stock market. Now, Michael Guillemette, an assistant professor of personal financial planning in the University of Missouri College of Human Environmental Sciences, along with David Nanigian, an associate professor at the American College, analyzed the causes of risk tolerance and found that loss aversion, or the fear of losing money, is the primary factor that explains investors' risk tolerance.

Read More »

Research Reveals Pervasive Implicit Hierarchies for Race, Religion, and Age

As much as social equality is advocated in the United States, a new study suggests that besides evaluating their own race and religion most favorably, people share implicit hierarchies for racial, religious, and age groups that may be different from their conscious, explicit attitudes and values.

Read More »

Girls who start dieting at a young age are more likely to be obese by 30

New research found that girls who begin dieting at a young age may face health problems later in life.

Read More »

Many depressed preschoolers still suffer in later school years

Children diagnosed with depression as preschoolers are likely to suffer from depression as school-age children and young adolescents, new research shows.

Read More »

Birth weight and breastfeeding have implications for children’s health decades later, study finds

Young adults who were breastfed for three months or more as babies have a significantly lower risk of chronic inflammation associated with cardiovascular and metabolic diseases, according to research from the Brown School at Washington University in St. Louis.

Read More »

Infants smell threats by mother's odor: Study

The sense of smell seems to be behind a mother's ability to pass specific fears to her infant in the first days of life. Scientists believe fear can be passed between generations, with mother to child the primary route.

Read More »

Preterm children's brains can catch up years later

There's some good news for parents of preterm babies - latest research from the University of Adelaide shows that by the time they become teenagers, the brains of many preterm children can perform almost as well as those born at term.

Read More »

First Grade Reading Suffers in Segregated Schools

A groundbreaking study from the Frank Porter Graham Child Development Institute has found that African-American students in first grade experience smaller gains in reading when they attend segregated schools-but the students' backgrounds likely are not the cause of the differences.

Read More »

Lifestyle affects risks of developing metabolic syndrome in childhood cancer survivors: Study

Leading a healthy lifestyle may lower childhood cancer survivors' risk of developing the metabolic syndrome, says a study.

Read More »

​Children with Disabilities Benefit from Classroom Inclusion

Language skills improve when preschoolers with disabilities are included in classes with typical peers

Read More »

Preschoolers With Special Needs Benefit From Peers’ Strong Language Skills

The guiding philosophy for educating children with disabilities has been to integrate them as much as possible into a normal classroom environment, with the hope that peers' skills will help bring them up to speed. A new study provides empirical evidence that peers really can have an impact on a child's language abilities, for better or worse.

Read More »

Real Time Analytics