October 26

Children and antidepressants – CNN Financial Today

Children and antidepressants – CNN Financial Today

Fri, 12 Nov 2004

When CNN was looking for an expert with a responsible, balanced view about the concerns of prescribing psychotropic drugs for children, they turned to AHRP.

We recommended psychiatrist, Dr. Joseph Glenmullen, a practicing clinician and Harvard faculty member, whose latest book, The Antidepressant Solution, is about to be released.

Dr. Glenmullen’s interview on Dolans Unscripted, CNN Financial, focused on the need for caution when prescribing psychotropic drugs – antidepressants and amphetamines–for children.

The program focuses on parenting in America – What are we doing right and wrong?

The segment airs today at: 10:00 – 11:00 AM and then re-airs at 8:00 PM and 11:00 PM.

* Dr. Glenmullen is a member of the AHRP board of directors

Below is a news report about new research findings that Prozac reduces bone formation in young mice, was published in the journal, Endocrinology. The finding may give parents added reason for caution about exposing their children to SSRI antidepressants.

The study found that mice exposed to Prozac for even a few weeks averaged 9.4 per cent less bone formation. The researchers found that ccompared to normal mice these animals had bones that were between 6 percent to 13 percent narrower on average. Their bones were also weaker and less dense.

The investigators note that studies in adults that linked long-term SSRI use with an increased risk for hip fracture, as well as reduced bone mineral density in the neck and spine.

This finding lends validity to Dr. Andrew Mosholder’s expressed concern in his 2001 medical review of the Prozac pediatric trials about evidence of growth reduction in children who took Prozac short term clinical trials. The drug was approved for use in children without further study.

As the investigator, Dr. Stuart Warden indicates:
“Bone development early in life is believed to determine lifelong skeletal health. Anything that affects normal bone development may have far-reaching consequences later in life when the skeleton is more prone to fracture.”

We need an independent clinical sciences institute to conduct drug research examining safety issues from a clinical perspective rather than a marketing perspective.

Contact: Vera Hassner Sharav
212-595-8974

http://www.innovations-report.com/html/reports/studies/report-36154.html
Innovations Report Indiana University

Common antidepressant may affect youth’s bone development
Effect of SSRIs on bone accrual

A common class of drugs prescribed to children with depression may have an adverse effect on bone growth, according to a study published online in the journal Endocrinology by researchers at the Indiana University School of Medicine.

Researchers looked at the effect of selective serotonin-reuptake inhibitors (SSRIs) on bone accrual in growing mice. The findings showed a reduction in bone mass and size in the mice administered an SSRI.

“These findings indicate a potential negative impact of SSRIs on the skeleton and point to a need for further research into the prescribing of these drugs to children and adolescents,” said lead author Stuart J. Warden, P.T., Ph.D., assistant professor in the Department of Physical Therapy, IU School of Health and Rehabilitation Sciences.

The study investigated the effects of fluoxetine, more commonly known as Prozac®, on bone growth in young mice. Dr. Warden and his colleagues selected fluoxetine because it is the only prescription antidepressant currently approved by the FDA for children and adolescents.

IU researchers began their investigation after preliminary clinical evidence released in other studies showed that SSRI use has been associated with increased bone loss at the hip in elderly women, decreased bone density among men and decreased skeletal growth in children.

It is estimated that as many as 10 percent of children and adolescents suffer from depression. “Bone development early in life is believed to determine lifelong skeletal health,” said Dr. Warden. “Anything that affects normal bone development may have far-reaching consequences later in life when the skeleton is more prone to fracture.”

THURSDAY, Nov. 11 (HealthDayNews) — The success of Prozac in easing depression in children may come at the price of impaired bone growth, suggests a study in mice.

Researchers say cellular mechanisms important to bone growth may shut down in the presence of the drug, hindering healthy skeletal development. Growing mice exposed to Prozac for even a few weeks averaged 9.4 percent less bone formation in their thighbones compared to unexposed mice, the researchers report.

“This is a mouse study, however, and I wouldn’t take people off Prozac based on just this study,” stressed lead researcher Stuart Warden, an assistant professor of physical therapy at Indiana University School of Medicine. “Still, as a researcher, I would start to think about planning trials to address this in a clinical population.”

In a statement, representatives from Eli Lilly & Co., the makers of Prozac, said “the findings warrant consideration, and should be placed in the context of the established record of safety and efficacy of fluoxetine [Prozac] in humans.”

The study is published in the November issue of Endocrinology.

Prozac is just one of a family of antidepressants called selective serotonin reuptake inhibitors (SSRIs), which also include Celexa, Paxil and Zoloft. All of these drugs interact with nerve cells to increase production of the neurotransmitter serotonin, which is low in people with depression.

However, researchers recently discovered that 5-HTT — a serotonin transporter molecule that is key to this process — is also found in cells responsible for building and maintaining bone.

“If you have serotonin around these cells and these cells have receptors, serotonin actually influences the activity of those bone cells,” Warden explained.

Using the same logic, his team theorized that serotonin-targeted SSRI drugs such as Prozac might also affect bone development.

To find out, they first examined bone growth in mice genetically engineered to lack functioning 5-HTT serotonin transporters in bone cells. A shutdown of this transporter “would be similar to being on lifelong Prozac, Zoloft or any other SSRI,” Warden explained.

Compared to normal mice, these animals had bones that were between 6 percent to 13 percent narrower on average. Their bones were also weaker and less dense.

The researchers then shifted their focus to short-term Prozac exposure, giving young, growing mice daily injections of either low- or high-dose Prozac, or placebo, for four weeks.

“When we gave Prozac to really young mice that were still rapidly growing, it reduced the amount of bone they gained,” Warden said. “It reduced their bone growth — not how long the bones were, but how wide, and how thick.”

Compared to unexposed mice, young mice exposed to relatively high doses of Prozac displayed a 6 percent and 9.4 percent reduction in bone formation in their spines and thighbones, respectively, according to the researchers. Warden stressed that the study focused on Prozac because it is the sole SSRI currently granted U.S. Food and Drug Administration approval for use in children. He believes other SSRIs would have similar effects on bone. “There’s no reason to believe Prozac is unique here,” Warden said.

For their part, representatives at Lilly said the study is far from conclusive. They point out, for example, that mice exposed to Prozac were somewhat less active than unexposed mice, offering an alternate explanation as to differences in bone mass.

They also defended Prozac’s safety record. “Lilly has sponsored five clinical trials of Prozac in children, and all have been published in independent, peer-reviewed journals,” the company said in a statement. “The safety and efficacy of Prozac is well-studied, well-documented, and well-established.”

But Warden believes that larger clinical trials are warranted. He pointed to studies in adults that linked long-term SSRI use with an increased risk for hip fracture, as well as reduced bone mineral density in the neck and spine.

Prozac has already faced intense public scrutiny recently, following reports suggesting that it and other SSRIs might raise suicide risks in children. “The main point of our study is not to induce panic in people on these drugs, but to highlight that further research is necessary,” Warden said. “We need to have independent studies looking at these drugs, so things aren’t brushed under the carpet.”

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