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“Use of Selective Serotonin Reuptake Inhibitors (SSRIs) in children and adolescents with major depressive disorder (MDD) - only fluoxetine (Prozac) shown to have a favourable Balance of risks and benefits for the treatment of MDD in the under 18s.”
Wonderful news once again coming out of the UK! What debt of gratitude we owe to those there who have worked so hard to bring this information out to the public and make positive changes!
Although the MHRA (which is the UK version of our FDA) has banned Zoloft, Celexa, Lexapro and Luvox for anyone under the age of 18, the exception is Prozac. This is probably because our own FDA approved this drug in children last January. Yet the agency did go on to state that the MHRA warns that, at best, Prozac helps only one child of 10. Clearly when these drugs all work the same way there are just as many serious problems with Prozac in children as there are in the use of its many clones which have now been banned.
Note that the article ends with this statement: “The SSRI review group, which has advised the Committee on the Safety of Medicines of the agency to ban the drugs from use in children, will now look at the safety and efficacy of the drugs in adults.”
So clearly the MHRA is not finished with their investigation but has only just begun!
For those of you who are interested, there will be a radio show this evening on the case of a 12 year old boy who shot and killed his grandparents and then burned their house down. He had taken Paxil and then was switched to Zoloft. He had taken the drugs for about two months when the tragedy happened. The show will be with radio host Jeff Rense at either 7:30 PM or 8:00 PM Pacific Time and can be heard live on line at www.rense.com. I will be on the show with the boy’s father, Lisa VanSyckel our NJ director and Jason Cato who is covering the story for the local newspaper.
Dr. Ann Blake Tracy, Executive Director, International Coalition For Drug Awareness& author of Prozac: Panacea or Pandora? - Our Serotonin Nightmare& tape on safe withdrawal “Help! I Can’t Get Off My Antidepressant!”
Order Number: 1-800-280-0730 Website: www.drugawareness.org
The British government has taken action to ban the use of antidepressant drugs of the selective serotonin reuptake inhibitors (SSRIs) in children and adolescents under the age of 18. They did this on the basis of an independent review of the safety and efficacy of the SSRI class in the treatment of children with major depression. http://www.mhra.gov.uk/
The review was undertaken by the Expert Working Group of the Committee on Safety of Medicines (CSM). The CSM has advised that THE BALANCE OF RISKS and BENEFITS for the treatment of major depressive disorder in under 18s IS JUDGED TO BE UNFAVORABLE for the following: sertraline (Zoloft), citalopram (Celexa) and escitalopram (Lexapro) and unassessable for fluvoxamine (Luvox). Only fluoxetine (Prozac) has been shown in clinical trials to have a favourable balance of risks and benefits for the treatment of MDD in the under 18s.
Meanwhile, the FDA has convened an advisory committee meeting to be held on Feb 2, 2004. However, FDA officials are attempting to block testimony by the very experts who provided the compelling scientific evidence that led the British authorities to take this action.
SSRIs are aggressively advertised and are, therefore, widely prescribed. However, the drugs have not shown a proven benefit greater than placebo for depression in company controlled clinical trials. See: The Emperor’s New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration. By Irving Kirsch, Thomas J. Moore, and Alan Scoboria and Sarah S. Nicholls. http://journals.apa.org/prevention/volume5/pre0050023a.html
Since their marketing in 1991, SSRIs have been at the center of controversy because of evidence showing that they cause severe adverse effects, even causing a small number of people—including children—to become suicidal. Furthermore, SSRIs cause severe withdrawal symptoms in a significant number of patients who are trying to stop taking them. See: http://www.socialaudit.org.uk/5100what.htm#5.1
The drugs’ manufacturers had vigorously denied evidence of harmful effects for years. But the concealed evidence came to light in several US lawsuits, and was further corroborated in a series of investigative reports in the Guardian and by Panorama for the British Broadcasting Corp. AHRP has the tapes of two Panorama programs.
The problem has been exacerbated by the FDA—the agency whose mission is to protect the public health is instead protecting the drug companies. FDA has remained silent about the evidence in its possession—some dating back to 1996—demonstrating the drugs’ hazards. Instead, FDA remained silent as drug manufacturers misled physicians and the public about the drugs’ hazards with false claims of their safety and effectiveness against depression. Indeed, GlaxSmithKline issued a Dear Doctor letters warning physicians in the UK about the hazards of Paxil for children—but no such explicit warning letter was issued to US doctors. Paxil was the first drug to be banned for children in Britain.
Prozac is the only antidepressant doctors in the UK are permitted to prescribe for children. It was approved for pediatric use by the FDA even though it has shown to bed helpful to only 1 in 10 depressed children.
The following documents provide detailed information about the drugs: Message sent to health professionals including a leaflet for patients (183KB) http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/cemss ri_101203.pdf
A question and answer document (131KB) http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ssriq a_101203.pdf
Overview of regulatory status and CSM advice relating to major depressive disorder (MDD) in children and adolescents including a summary of available safety and efficacy data (300KB) http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/ssrio verview_101203.pdf
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org
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Modern antidepressant drugs which have made billions for the pharmaceutical industry will be banned from use in children today because of evidence, suppressed for years, that they can cause young patients to become suicidal.
The Medicines and Healthcare Products Regulatory Agency (MHRA) told doctors last night not to prescribe all but one of the antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
The exception is Prozac, which is licensed for use in depressed children in the US. But the MHRA will warn that, at best, it helps only one child in 10.
The decision has big implications for drug regulation.
The agency - which is the government’s watchdog body on drug safety - has reached this point only after intense pressure from patients and campaigners.
They were concerned about patients - at first mainly adults - who appeared to have become suicidal on the drugs, and others who had got hooked and suffered distressing symptoms when they tried to stop taking them.
Public unease about these potential side-effects prompted the agency to investigate last year. It has looked at the details of clinical trials of depressed children that were in the hands of the drug companies in the late 1990s. These studies revealed the problem of suicidal behaviour in children, but the companies did not draw it to the attention of the regulators in the US or the UK.
It has become clear from the investigation that the regulators generally see only a summary of the data resulting from trials. It is prepared for them by the drug company only when it is seeking a licence.
The agency became aware of a problem with Seroxat in children this year only when the manufacturer, GlaxoSmithKline, submitted data from trials which finished in 1996.
Pressure for a change in the regulatory system will inevitably grow.
Two of the SSRI class of drugs have already been banned - or, technically, contra-indicated in children - by the agency.
The first, in June, was Seroxat, which goes by the generic name paroxetine; the second, in September, was Efexor (venlafaxine); joining them now will be Lustral (sertraline), Cipramil (citalopram), Cipralex (escitalopram) and Faverin (fluvoxamine).
Trials on children have not been carried out in all the drugs, but the completed studies show a worrying increase in suicidal behaviour among those on SSRIs compared with those given a placebo (sugar pill).
None of the drugs has a licence for use in children with depression in the UK, but GPs have prescribed more and more SSRIs for children.
It is estimated that as many as 50,000 children on antidepressants in Britain.
The agency will warn that patients should not stop their medication suddenly to avoid withdrawal symptoms.
The ban will cause problems for doctors because insufficient counsellors and psychotherapists are available to offer the alternative treatment of therapy, and the bill to the NHS for such treatment would be much higher than the cost of the drug prescriptions.
Drug companies began clinical trials on the safety and efficacy of the SSRIs in children only after prompting by the US food and drug administration in the early 90s.
David Healy, the director of the North Wales department of psychological medicine, said: “It was standard practice for the FDA approving drugs like Seroxat (Paxil in the US) for adults in 1991 to write to the company and say this drug will also be used in children - it would be helpful if you could run trials in children so we can see what the safety profile is.”
But trials that did not produce favourable results were neither published nor sent to the FDA or the MHRA.
The first major Seroxat trial in children was finished by 1996, but the results were not published until 2001. Data was also gathered in 1996 after a trial of Lustral, manufactured by Pfizer, showing that 9% of depressed children on the drug became suicidal.
Dr Healy, whose own researches led to the establishment of the SSRI review, said yesterday: “They should have known by 1996 that there was a problem. GSK and Pfizer were asked to do this by the regulators so that we knew what the safety issues were.”
The drug companies dispute that a problem exists. Only a tiny minority of children taking the drug become suicidal and their depression could be the real cause, they claim. GSK says several trials, not just one, were needed to establish whether its drug caused problems.
The SSRI review group, which has advised the Committee on the Safety of Medicines of the agency to ban the drugs from use in children, will now look at the safety and efficacy of the drugs in adults.
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