Posts Tagged ‘selective serotonin reuptake inhibitor’

Can Prozac Cause Kids to Kill? A Canadian Judge Has Ruled it Can

Wednesday, December 7th, 2011

Note from CCHR:

(see videos at the bottom of this post from film maker Michael Moore and Fox National News reporter Douglas Kennedy)

It is well documented that psychiatric drugs, particularly antidepressants, can cause a host of violent side effects including mania, psychosis, aggression, violence and in the case of the antidepressant Effexor, homicidal ideation.   As far back as 1991, CCHR helped organize dozens of individuals and experts testifying before the US FDA that people with no prior history of violence (or suicide) became homicidal and suicidal under the influence of antidepressants (see CCHR’s exclusive footage of the 1991 hearings here).  It would take the FDA another 13 years to admit antidepressants could cause suicide and black box warnings were finally issued in 2004.  However, despite all the documented violence-inducing side effects of these drugs, the FDA has never issued black box warnings on antidepressants causing violence or homicide despite the fact that at least 11 recent school shootings were committed by kids documented to be on or in withdrawal from psychiatric drugs (see Fox News special report on school shootings here).   Therefore, the case cited below, where a Canadian judge ruled that a teenage boy murdered his friend due to being on the antidepressant Prozac, and the fact that the case will not be appealed, is a major turning point in exposing the violence inducing effects of antidepressant drugs.  

National Post
By Tom Blackwell
December 7, 2011

JB Reed/Bloomberg News

A Winnipeg judge’s ruling that a teenage boy murdered his friend because of the effects of Prozac will not be appealed, confirming an apparent North American first and reviving debate around the widespread prescription of anti-depressants to young people.

Justice Robert Heinrichs concluded the 15-year-old boy was under the influence of the medication when he thrust a nine-inch kitchen knife into the chest of Seth Ottenbreit, a close friend.

Although the killer pleaded guilty to second-degree murder, the judge cited the drug’s alleged side effects as a reason not to raise the case to adult court, and to mete out a sentence last month of just 10 months – on top of two years already spent in jail.

A spokeswoman for the Manitoba Justice Department said this week prosecutors have decided not to appeal the provincial-court decisions, which were earlier met with outrage from Mr. Ottenbreit’s family and friends.

Both the boy’s lawyer and the psychiatrist who testified on his behalf say it is the first time a criminal-court judge in North America has made such a finding.

Prozac is meant to curb the effects of depression, but Justice Heinrich concluded it set off a steady deterioration in the young murderer’s behaviour.

“He had become irritable, restless, agitated, aggressive and unclear in his thinking,” the judge said. “It was while in that state he overreacted in an impulsive, explosive and violent way. Now that his body and mind are free and clear of any effects of Prozac, he is simply not the same youth in behaviour or character.”

Yet the empirical underpinning of his conclusion, and the pros and cons of young people taking Prozac and other “selective serotonin reuptake inhibitor (SSRI)” anti-depressants, seem less clear-cut.

Justice Heinrichs relied largely on the expert testimony of Dr. Peter Breggin, a controversial American physician known for his outspoken opposition to the use of virtually any psychiatric drug. Some other experts say scientific evidence of a link between the latest anti-depressants and homicide is thin.

“I think it got pulled out of a hat, frankly,” said Dr. Umesh Jain, a child and adolescent psychiatrist at Toronto’s Centre for Addiction and Mental health. “You could construct a weak and biologically plausible effect, but you’d have to be pretty convincing in court.”

Studies have established such drugs can increase the risk of young patients having suicidal thoughts. Their tendency to lift inhibition could also release some hostility or violence lurking in a person’s character, said Dr. Jain. Small studies like one he co-authored in 1992 have also suggested that the drugs can trigger short-term mania, especially in bi-polar disorder patients.

There is little or no scientific evidence directly linking the anti-depressants and serious violence or homicide, though, he said.

Still, the official “product monograph” approved by Health Canada for Prozac says the drugs are not recommended for use on adolescents, and warns that agitation, hostility and aggression might ensue. Doctors are allowed to prescribe medications “off label” to patients even when the approval does not expressly permit it.

Specialists in Winnipeg responded to concerns voiced by the accused’s parents by actually increasing the dose, said Greg Brodsky, the teenager’s lawyer.

“On Prozac he was becoming more irrational and aggressive,” Mr. Brodsky said. “That should have been a warning. That warning wasn’t heeded.”

SSRI drugs have a contentious track record. They were hailed originally as a safe alternative to older anti-depressants, then clinical-trial results came to light in 2004 that suggested they increased the risk of children and adolescents having suicidal thoughts.

Other studies have indicated they are effective in patients with major depression, but little better than a placebo for mild to moderate cases.

The Winnipeg murderer had a history of smoking marijuana, had abused prescription drugs and “experimented” with cocaine, but was trying to break free of that background when a family doctor prescribed Prozac for depression in July, 2009.

On Sept. 20, the accused met with Mr. Ottenbreit and another friend at his house, after the two friends had earlier stormed into his home, allegedly damaging the floor. The killer and Mr. Ottenbreit shared a cigarette, before the accused pulled aside a sweater on the floor of his garage, revealing the knife. He picked it up, “got this weird look on his face,” then abruptly stabbed his friend, the other boy told police.

“They were in my house, they dented the floor, I had nothing else to do but to stab him,” he told police later.

Dr. Keith Hildahl, clinical head of Winnipeg’s Child and Adolescent Mental Health program, testified that the Prozac might have played a role, but concluded on balance that his behaviour that summer was largely a result of the tense relationship he had with his parents.

Dr. Breggin, who has testified in a number of U.S. cases where anti-depressants allegedly led to murder or other violence and reviewed the Winnipeg case, pointed the finger of blame at the medication.

“These drugs produce a stimulant or activation continuum,” he said in an interview. “That continuum includes aggression, hostility, loss of impulse control … all of which are a prescription for violence.”

Dr. Breggin’s long-standing criticism of psychiatric drugs and opposition to the view that psychiatric problems have biochemical roots have prompted some supporters to call him the “conscience” of the speciality, and some psychiatrists and patient advocates to condemn him as a harmful influence.

Read article here:  http://news.nationalpost.com/2011/12/07/prozac-defence-stands-in-manitoba-teens-murder-case/

See Michael Moore discuss the need for an investigation into psychiatric drugs causing violence:

See Fox National News on School Shootings and Psychiatric Drugs:

To read international warnings and studies on psychiatric drugs causing violence – visit CCHRInt’s Psychiatric Drug database and simply type in keywords such as violence, mania, psychosis, aggression in the red search box

« Return to news items


Share

New Review of FDA antidepressant drug trials suggests antidepressants only “marginally better” than placebo – Ineffectiveness of antidepressants called “jaw-dropping”

Tuesday, August 24th, 2010

Medscape
By Deborah Brauser
August 24, 2010

A new review of 4 meta-analyses of efficacy trials submitted to the US Food and Drug Administration (FDA) suggests that antidepressants are only “marginally efficacious” compared with placebo and “document profound publication bias that inflates their apparent efficacy.”

In addition, when the researchers also analyzed the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, “the largest antidepressant effectiveness trial ever conducted,” they found that “the effectiveness of antidepressant therapies was probably even lower than the modest one reported…with an apparent progressively increasing dropout rate across each study phase.

“We found that out of the 4041 patients initially started on the SSRI [selective serotonin reuptake inhibitor] citalopram in the STAR*D study, and after 4 trials, only 108 patients had a remission and did not either have a relapse and/or dropped out by the end of 12 months of continuing care,” lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC in Clarksville, Maryland, told Medscape Medical News.

Sustained Benefit “Jaw Dropping”

“In other words, if you’re trying to look at sustained benefit, you’re only looking at 2.7%, which is a pretty jaw-dropping number,” added Dr. Pigott.

Overall, “the reviewed findings argue for a reappraisal of the current recommended standard of care of depression,” write the study authors.

“I believe there are likely some people where [antidepressants] are truly beneficial beyond placebo. The problem right now is that we simply have no way of knowing who those people are,” noted Dr. Pigott. “My hope is that this kind of analysis creates ‘more oxygen’ for looking at other kinds of approaches to treatment.”

The study was published in the August issue of Psychotherapy and Psychosomatics.

When registering new drug application trials with the FDA, drug companies must prespecify the primary and secondary outcome measures, the investigators report. “Prespecification is essential to ensure the integrity of a trial and enables the discovery of when investigators selectively publish the measures that show the outcome the sponsors prefer following data collection and analysis, a form of researcher bias known as HARKing or ‘hypothesizing after the results are known’,” they write.

For this article, Dr. Pigott and his team reviewed the following meta-analyses:

  • 1. Rising and colleagues (reviewed all efficacy trials for new drugs between 2001 and 2002)
  • 2. Turner and colleagues (reviewed 74 past trials of 12 antidepressants)
  • 3. Kirsch and colleagues, 2002 (reviewed 47 trials of 6 FDA-approved antidepressants)
  • 4. Kirsch and colleagues, 2008 (reviewed depression severity and efficacy in 35 trials)

The researchers also sought to reevaluate the methods and findings of STAR*D, a randomized, controlled trial of patients with depression. Its prespecified primary outcome measure was the Hamilton Rating Scale for Depression (HRSD), whereas the Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30) was secondary for identifying remitted and responder patients.

“STAR*D was designed to identify the best next-step treatment for the many patients who fail to get adequate relief from their initial SSRI trial,” the study authors write.

“When I first read about STAR*D’s step 1 phase, it just seemed biased to me,” explained Dr. Pigott. “I thought of it as the ‘tag, you’re healed’ research design. Patients who were scored as having a remission during the first 4 to 6 weeks of up to 14 weeks of acute care treatment were counted as remitted, taken out of the subject pool, and put into the follow-up care phase. In other words, they didn’t have the ability to have a relapse. But as most people know, depression ebbs and flows.

“So what made me want to continue to follow this study was that it became clear that the only way that people were really going to be able to evaluate the antidepressants’ effectiveness was to wait for the publication of the follow-up findings,” he added. “After their major final summary study was published, I felt as though the results weren’t really being portrayed in a manner that was consistent with the study’s prespecified criteria.”

High Dropout, Low Remission Rates

In addition to reporting on low efficacy of antidepressants compared with placebo, the 4 meta-analyses “also document a second form of bias in which researchers fail to report the negative results for the prespecified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure, as though it was their primary measure of interest,” the investigators write.

For example, they note, the meta-analysis from Rising and colleagues found that studies with favorable outcomes were almost 5 times more likely to be published and that over 26% of primary outcome measures were left out of journal articles. Turner and colleagues found that antidepressant studies were 16 times more likely to be published if favorable compared with those with unfavorable outcomes.

In reanalyzing the STAR*D methods, the researchers found that the high dropout rate resulted in frequently missed exit HRSD and IDS-C30 interviews. So the revised statistical analytical plan dropped the IDS-30 for the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), which was given at each visit.

“Even with the extraordinary care of STAR*D, only about one fourth of patients achieved remission in step 1 [and] the dropout rate was slightly larger than the success rate,” the study authors write. Steps 2 through 4 also each showed increasingly fewer success rates and larger dropout rates.

Of the 4041 patients at the study’s initiation, 370 (9.2%) dropped out within 2 weeks, and only 1854 patients (45.9%) obtained remission “using the lenient QIDS-SR criteria.” Of these, 670 dropped out within a month of their remission, and only 108 “survived continuing care” and underwent the final assessment.

Dr. Pigott described reanalyzing STAR*D as being “a bit like an onion. Each time we thought we understood the results, we found another layer. It wasn’t until about a year and a half ago that we discovered that the secondary outcome measure, the QIDS-SR, was not originally supposed to be used as a research measure. What was particularly disconcerting to me was that in their summary article, they basically used the QIDS-SR to report all of the results, which clearly had an inflationary effect on the outcome.”

He also noted that STAR*D did not have a placebo design. “Because the patients knew they were receiving the active medication, I would have expected a higher remission rate than what you’d find normally in a placebo-controlled study.

“The inescapable conclusion from the STAR*D results is that we need to explore more seriously other forms of treatment (and combination thereof) that may be more effective. This effort will require developing new service delivery models to ensure that as treatments are identified, they are widely implemented,” the investigators conclude.

Read entire article here:  http://www.medscape.com/viewarticle/727323
(Free registration required)

« Return to news items


Share

Psychiatric Meds 101—A layman’s guide to drug side effects—by award winning Scientist Shane Ellison

Wednesday, July 21st, 2010

By Shane “The People’s Chemist” Ellison
Author, Over-The-Counter Natural Cures

I may be a perfect candidate for psychiatry.

I ask questions with period marks to shorten conversations. I avoid eye contact with strangers in fear (maybe it’s anxiety) that I might learn too much about them. I secretly think that Metallica would be making better music if they went back to bludgeoning themselves with party drugs and alcohol, instead of “therapy.” I’m trying to master the Law of Un-attraction to shield myself from a “real job,” small homes and junky cars.  And, I’m constantly giving my children advice, only to give it to myself.

Psychiatry, can your drugs help me?

Perhaps these questions are what motivated me to pursue a career as a drug design chemist, winning multiple awards for my work. Nothing gets me more excited than drugs and how they affect the body (except my wife’s abs). I’ve studied their molecular anatomy, risked life and limb to mix and match explosive chemicals in a round bottom flask, and even sold my soul to Big Pharma in exchange for a lab bench and chemical hood.

During this time, I’ve made some surprising discoveries about psychiatric meds, which include antidepressants, antipsychotics, stimulants, and anti-anxiety drugs. Understanding what I’ve learned will protect you from the flood of side effects that are now being discovered at breakneck speeds, courtesy of the myriad of patients being prescribed psychiatric drugs in the name of mental health.

Your Own Personal Hell

Antidepressants strive to increase the levels of a “coping” molecule known as serotonin in the brain. It supposedly helps us find happiness when it’s covered in an avalanche of nastiness. But, it’s never been proven. Still, the drugs attempt to boost serotonin by “selectively” stopping the “reuptake” among brain cells. This is where the whole SSRI acronym came from—“selective serotonin reuptake inhibitor.” It’s a slick name, but a stupid idea. Nothing is selective in the body.

Read the rest of this article here: http://www.cchrint.org/2010/07/20/psychiatric-meds-101-a-surprising-discovery/

« Return to news items


Share

Psychiatric Meds 101: A Surprising Discovery – Your Own Personal Hell

Tuesday, July 20th, 2010

Mouse over image and click to see next slide. To copy/post slideshow use the embed code at bottom of page.

By Shane “The People’s Chemist” Ellison
Author, Over-The-Counter Natural Cures

I may be a perfect candidate for psychiatry.

I ask questions with period marks to shorten conversations. I avoid eye contact with strangers in fear (maybe it’s anxiety) that I might learn too much about them. I secretly think that Metallica would be making better music if they went back to bludgeoning themselves with party drugs and alcohol, instead of “therapy.” I’m trying to master the Law of Un-attraction to shield myself from a “real job,” small homes and junky cars.  And, I’m constantly giving my children advice, only to give it to myself.

Psychiatry, can your drugs help me?

Perhaps these questions are what motivated me to pursue a career as a drug design chemist, winning multiple awards for my work. Nothing gets me more excited than drugs and how they affect the body (except my wife’s abs). I’ve studied their molecular anatomy, risked life and limb to mix and match explosive chemicals in a round bottom flask, and even sold my soul to Big Pharma in exchange for a lab bench and chemical hood.

During this time, I’ve made some surprising discoveries about psychiatric meds, which include antidepressants, antipsychotics, stimulants, and anti-anxiety drugs. Understanding what I’ve learned will protect you from the flood of side effects that are now being discovered at breakneck speeds, courtesy of the myriad of patients being prescribed psychiatric drugs in the name of mental health.

Your Own Personal Hell

Antidepressants strive to increase the levels of a “coping” molecule known as serotonin in the brain. It supposedly helps us find happiness when it’s covered in an avalanche of nastiness. But, it’s never been proven. Still, the drugs attempt to boost serotonin by “selectively” stopping the “reuptake” among brain cells. This is where the whole SSRI acronym came from—“selective serotonin reuptake inhibitor.” It’s a slick name, but a stupid idea. Nothing is selective in the body.

While trying to block the reuptake of serotonin, antidepressants can also prevent its release and that of another brain compound known as dopamine. The areas of the brain responsible for release and reuptake of these neurotransmitters are so damn similar (after all, they work on the same molecule) that an antidepressant drug isn’t smart enough to understand which one it is supposed to work on. So it does what any dumb drug would do, it blocks both. That’s why users usually carry a glassy stare in their eye. Fully under the psychiatric spell, they’ve tuned out.

Deep sadness, fear, anger and aggression can set in over time. By removing serotonin and dopamine from the brain, long-term antidepressant users can’t find or feel happiness. Instead, they may become buried in the avalanche of nastiness. And if you can’t find or feel happiness in life, what’s the point? What’s going to stop you from snapping your own neck or spraying bullets on your classmates? Not much when you live in your own personal antidepressant hell.

Think this is all opinion?

According to the FDA, antidepressants can cause suicidal thoughts and behavior, worsening depression, anxiety, panic attacks, insomnia, irritability, hostility, impulsivity, aggression, psychotic episodes and violence.  Some even cause homicidal ideation according to the manufacturers. Many long-term antidepressant users will tell you they no longer feel normal emotions—they’re numb, like zombies.

But the side effects of these drugs aren’t limited to hijacking your feelings and emotional state, causing violent and psychotic states. Physical side effects occur too and include abnormal bleeding, birth defects, heart attack, seizures and sudden death. Over one hundred and seventy drug regulatory warnings and studies have been issued on antidepressants, to sound the alarm on these side effects.

For Elephant Use Only

Psychiatrists prescribe antipsychotic meds such as Zyprexa and Seroquel, for anything from schizophrenia, bipolar disorder, delusional disorder, psychotic depression, autism or anything else they can think of, even “pervasive developmental disorder,” which is perfect for boosting sales because it targets children who suffer from irritability, aggression, and agitation. It’s a shame ‘cause these drugs are good for nothing but sedating irate elephants, not curing psychiatric disease.

According to a study published in Psychological Medicine, antipsychotic drugs cause brains to shrink – they lessen brain matter and volume. Originally designed for those deemed “schizophrenic,” the drug companies came up with a brilliant marketing campaign to sell these drugs to a much wider market—unsatisfied antidepressant users. You’ve probably seen the ads—if your “depression medication” isn’t working, then don’t blame the drug; you may just have bipolar disorder!

Once swallowed, antipsychotics sail through the blood stream where they’re carried to the brain. Like a giant oil spill, antipsychotics cover the brain in a medicinal slick, where brain wave transmission is blocked. Users become devoid of normal brain activity. Motivation, drive and feelings of reward are shunted. If psychiatry considers this a “treatment,” they’re the crazy ones.

If you’ve ever seen someone who has suffered from the “spill” courtesy of following doctors orders, you can’t mistake one of the most common side effects, it’s called Akathisia. Involuntary movements, tics, jerks in the face and the entire body can become permanent side effects for antipsychotic users.

Antipsychotics also cause obesity, diabetes, stroke, cardiac events, respiratory problems, delusional thinking and psychosis. Drug regulators from the U.S., Canada, United Kingdom, Ireland, Australia, New Zealand and South Africa warn that they can also lead to death. I wouldn’t be surprised if psychiatrists considered this a cure…

Use This to Jump The Grand Canyon

If you’re going to attempt to jump your scooter over the Grand Canyon, or ride your snowboard off Kilimanjaro, stimulants are great. They flood the brain with dopamine and trigger an inhuman surge of adrenaline, responsible for making you believe life is grand, despite eminent death. Outside of that, you’re either a speed freak, a college student trying to learn an entire semester of Biology 101 in 4 hours, or a fifth grader “following doctor’s orders.”

Top stimulants being prescribed today are nothing more than a mix of amphetamines packaged into trade names like Adderall, Dexedrine and Ritalin.  Street thugs sell it as meth, poor man’s cocaine, crystal, ice, glass and speed. It’s no wonder kids are now abusing Ritalin, Adderall and these drugs more than street drugs, they’re cheaper to get and they’re “legal,” hence the term kiddie cocaine.

Even the U.S. Drug Enforcement Administration (DEA) categorizes Ritalin in the Schedule ll category, meaning a high potential for abuse—just like cocaine and morphine. All of them have the same effects regardless of how they’re named: Central nervous system overload leading to heart attack and/or heart failure. And kids are dropping faster than Meth Heads at Raves…

I’m not exaggerating.

Eleven international drug regulatory agencies and our own FDA has issued warnings that stimulants like Ritalin cause addiction, depression, insomnia, drug dependence, mania, psychosis, heart problems, stroke and sudden death.

 Bash Your Head in with Anti-Anxiety Drugs

If you’re not man enough for a drug that could sedate an elephant like antipsychotics, then psychiatrists will prescribe anti-anxiety meds, particularly benzodiazepines. Choosing between the two is akin to deciding whether or not you should be hit in the head with an aluminum bat or a wooden one; anti-anxiety meds being the latter.

Discovered in the stinky chemistry labs of Hoffman La Roche in 1955, anti-anxiety meds aim to trigger sleep receptors in the brain, just slightly. So, rather than being riddled with anxiety, you are put to sleep, halfway. It’s “treatment,” and psychiatrists have been “practicing it for decades.” But, it has yet to work, because drugging your problems away is more dangerous than anxiety. The use of anti-anxiety meds is coupled with a host of nasty side effects such as seizures, aggression and violence once the drug wears off. Hallucinations, delusional thinking, confusion, abnormal behavior, hostility, agitation, irritability, depression and suicidal thinking are all possible outcomes according to Big Pharma’s heavily guarded research papers.

Getting off the drugs could be harder than abandoning a heroin addiction. Some have described withdrawal from “benzos” being akin to pulling hundreds of fish hooks out of their skin, without anesthesia. If you doubt their addictive nature, go to Google search and type in a few of the leading anti-anxiety drugs like Klonopin or Xanax and here is what you’ll find:

“Klonopin withdrawal” 1,860,000 results

“Xanax withdrawal” 1,980,000 results

Exposing Psychiatry: How to Get The Truth

In total, the side effects of psychiatric meds spread far and wide. And most are hidden from patients and doctors alike. Fortunately, Citizens Commission on Human Rights has solved this problem with a state-of-the-art database that allows people to search through the adverse reaction reports sent to the FDA on psychiatric drugs. It also provides international drug regulatory agency warnings and studies published on the side effects of the drugs.

So, can psychiatry help me? No. And that’s surprising because psychiatric meds are some of the biggest selling drugs, poised to seal the hopes and dreams of millions.  Regardless of what mental state I might be in (or anyone else for that matter), there is not a single drug that cures, treats or solves the perceived problems of mental health.

While people can suffer miserably from emotional or mental duress that can hinder their lifestyle, the pseudo-science of psychiatry has yet to solve any of these problems, and in fact only contributes to poor health as seen by the wide array of side effects. Marketing campaigns and ghostwritten medical journals are designed to obscure these facts. But the psychiatric drug side effect database courtesy of CCHR ensures that all patients have access to the truth, to the documented facts, which could save their life or that of a loved one.

 About the Author

Shane Ellison holds a masters degree in organic chemistry and is the author of Over-The-Counter Natural Cures.  An award winning chemist, he has been quoted by USA Today, Shape, Woman’s World, as well as Women’s Health and appeared on Fox and NBC as a natural medicine advocate.  Sample his book free at www.thepeopleschemist.com

————————————————————————–

To use this slideshow on your own website, you can use one of these two embed codes:

<object data=”http://www.cchrint.org/slideshow/index.html” width=”593″  height=”440″ style=”overflow:hidden; height:440px; width:593;”><embed src=”http://www.cchrint.org/slideshow/index.html” width=”593″ height=”440″ style=”overflow:hidden; height:440px; width:593;”> </embed>Error: Embedded data could not be displayed.</object>

OR

<iframe src=”http://www.cchrint.org/slideshow/index.html” width=”593″  height=”440″ style=”border:none; overflow:hidden;”></iframe>

RETURN TO BLOGS PAGE


Share

Medscape – Psychotropic Medications Linked to Serious Adverse Drug Reactions in Children

Friday, July 2nd, 2010

Medscape
By Deborah Brauser
July 2, 2010

Psychotropic medications are associated with adverse drug reactions (ADRs), many of which are serious, in children younger than 17 years, according to a new database study from Danish researchers.

Results also showed that all but one of the psychotropic-related ADRs for children between the ages of birth and 2 years were serious, including birth defects such as neonatal withdrawal syndrome, ventricular septal defects, and premature labor.

These findings were “probably due to the mothers’ intake of psychotropic medicine, primarily antidepressants and antipsychotics, during pregnancy,” write the study authors.

For the overall patient population, the largest share of reported ADRs came from psychostimulants (42%), followed by antidepressants (31%) and antipsychotics (24.5%).

“The high number of serious ADRs reported for psychotropic medicines in the pediatric population should be a concern for health care professionals and physicians,” the study authors write.

In addition, “clinicians must be aware of the risks for the unborn child if they treat pregnant women with [these drugs],” coinvestigator Ebba Hansen, MSc, professor of social pharmacy and director for the FKL-Research Center for Quality in Medicine Use at the University of Copenhagen, Denmark, told Medscape Medical News.

She noted that many of the general practitioners interviewed for this study “thought that SSRI [selective serotonin reuptake inhibitor] antidepressants are harmless. Therefore, we recommend that treatment of pregnant women with psychotropic drugs should be an issue for specialists only.”

The study is published online in BMC Research Notes.

ADR Evidence Lacking

Although regulatory authorities have issued warnings about risks associated with the use of psychotropics in pediatric patients, “little evidence has been reported about the ADRs of these medicines in practice,” write the study authors.

“Overall, we have very little information about [ADRs] in children, and especially in infants, as vulnerable groups are excluded from the clinical trials that document a medication’s efficacy and safety before licensing and marketing,” said Professor Hansen.

For this study, her team evaluated 4500 ADRs in children listed in the national Danish ADR database between 1998 and 2007.

“Spontaneous ADR reporting [is] an important contributor to knowledge about safety of medicines,” the study authors write. They note that spontaneous reports are “the main source for information about new and previous unknown ADRs.”

Serious ADRs Found

Results showed that 429 of the ADRs reported during the study period were for psychotropic medications. Of these, 241 (56%) were deemed serious.

A total of 50% of the psychotropic ADRs reported were for adolescents between the ages of 11 and 17 years (n = 214), of which 45% were serious. Almost 19% were for children between the ages of birth and 2 years (n = 80).

In addition, 39% of the overall psychotropic-related ADRs were from the “nervous and psychiatric disorders” categories. When looking at sex, 59% of the total ADRs reported were for boys.

A total of 79 of the 80 ADRs associated with psychotropics in the children younger than 2 years were serious, and 2 of these were fatal (one was associated with citalopram due to chorioamnionitis and the other with fluoxetine due to persistent fetal circulation).

Finally, 40% of all psychotropic ADRs were associated with the psychostimulants methylphenidate and atomoxetine, whereas 59% of the ADRs reported for antipsychotics were associated with ziprasidone, olanzapine, and risperidone. A total of 61% of the total ADRs reported for antidepressants were with sertraline and citalopram.

Read entire article:  http://www.medscape.com/viewarticle/724547
(Free registration required for Medscape)

« Return to news items


Share

UK Drug Regulatory Agency issues warning about potential birth defects from Prozac

Thursday, April 29th, 2010

Lawyers & Settlements
By Heidi Turner
April 28, 2010

London, England: The Medicines and Healthcare Products Regulatory Agency (MHRA), the government agency in the UK responsible for medicines and medical devices, has issued a warning about potential SSRI birth defects related to the use of fluoxetine (Prozac).

The MHRA issued the warning in its monthly drug safety update. The agency warns that there is a small risk of congenital cardiac defects in infants of mothers who took fluoxetine during the first trimester of pregnancy. According to the safety update, the risk is similar to that posed by paroxetine (Paxil/Seroxat).

The MHRA notes that an analysis of data from seven cohort studies found a slightly increased risk of congenital cardiac defects when fluoxetine was taken early in pregnancy. Those cardiac defects reportedly varied and ranged in severity from reversible ventricular septal defects to transposition of the great vessels. The safety update notes that the increased absolute risk is less than two per 100 pregnancies.

Prozac is an antidepressant classed as a selective serotonin reuptake inhibitor (SSRI). The MHRA says that there is not enough data to conclude that other SSRIs carry the same risk, but it is unwilling to rule out the possibility of a “class effect,” meaning other drugs in the same class may carry the same risks.

The agency also says that the risk of giving birth to an infant with congenital cardiac defects should be weighed against the risks of having untreated depression during pregnancy, which carries its own risks, including low birth weight, preterm delivery and lower Apgar scores.

Read entire article:  http://www.lawyersandsettlements.com/articles/14025/interview-ssri-birth-defects-side-effects-pphn.html

« Return to news items


Share