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How are Drugs Approved for Children

How are Drugs Approved for Children

Friday, July 2nd 2004

In New Zealand, most people assume that all prescription medicines are 'safe' because they are approved by the Minister of Health and vetted by Medsafe (Ministry of Health). Regretfully the truth is far removed from the perception.

Children as young as two are apparently being prescribed powerful mood-changing drugs such as Prozac and other anti-depressants. The number of two to four year olds taking stimulants (such as Ritalin), anti-depressants (such as Prozac) and antipsychotics has skyrocketed.

Around the Western World, the increase in government sanctioned drugged children is appalling. In America the increase is 400% and around 2% of youths are taking anti-depressants. In France, 12% of children starting school were receiving psychotropic medicines and 76% started before the age of four. Last year in the United Kingdom, doctors wrote 170,000 children's prescriptions for anti-depressants.

Worse still is that only 8% of GP's and Pediatricians have received adequate training in the management of childhood depression. Yet, 72% prescribed drugs such as Prozac to children under 18 (Pediatrics, 2000;105 Ed82) and 57% prescribed an SSRI for children with problems other than depression.

How are they approved?

Once a drug is approved by the Minister of Health and on the market, further studies to determine safety and effectiveness in infants and children are very rarely conducted. (Curr Opin Pediatr 1995;7:195-8) Many medicines used for children are not licensed (do not have marketing authorisation) or are used outside the terms of the products license approval.

Such prescriptions depend on little more than 'educated guesswork'. They are not supported by scientific evaluation. This practice has been officially endorsed by the 'regulators' and western governments since the 1960's and the unapproved prescribing to children is now a world-wide phenomenon.

Prescription drug safety in children cannot be inferred from widespread use. Nor can safety in adults be used to infer safety in children as they often react to drugs in a totally different way to adults. Phenobarbital is a good example where it acts like a sedative in adults, yet produces hyperactivity in children. Ritalin, a cocaine-like drug, is used as an antihyperactive drug in children but is a stimulant in adults.

Recently, concern has been raised about SSRI's and their possible association with increased suicide risk in children. Two of these drugs have been banned in the UK, Canada and Ireland (but not NZ) for children. Apparently the manufacturers decided to conceal evidence from controlled clinical trials indicating adverse effects in children.

Now is the time for parents to start actively looking for signs of subtle changes in the developing personalities of their children, which could be the direct result of mood-altering drugs on the neurotransmitters of the brain.

Reproduced unabridged from the July - September 2004 issue of Health and Herbal News, with the kind permission of Health and Herbs International Ltd.

Footnote from Ideal Health:

The following products are all useful for improving mood:

5-HTP 120mg
5HTP Mood Care
Adrenal Formula
Adrenal Support
Clinical Strength St Johns Wort
Daily D
Magnesium Complex
Mega Magnesium Powder
Mineral Power
Multi Power
Rescue Remedy Pastilles
Super B Daily Stress +
Stress & Energy Support
Stress & Well-Being
Superior Magnesium
Supreme Hi-B-125
Whey Protein - Vanilla

Related health information can be found here:

Calcium Deficiency
Calcium to build bones
Depressed, anxious or unable to sleep? You could be low in the brain chemical serotonin
Essential oils for your emotions
Hypericum St John's Wort - depression, NS complaints
Mineral Power

Related articles can be found here:

Childhood vaccination: Is there a "dark side"
Chlorophyll- nature's green wonder food
First, Reduce Stress then.... Soothe & Stabilise Mood
Minerals: Critical for well-being
Mood, sleep, serotonin and 5-HTP
New Study Links Low Cholesterol to Suicide in Depressed Patients
Not only to fight obesity and depression - Rhodiola - more powerful than Ginseng!
St John's Wort Extract

If you need help or advice, you are welcome to email our naturopathic team with your health question.

Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.


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