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Think Ritalin Is Safe? - Read
What Novartis Says About
Its Own Product!

By Joel Bainerman
isratech@netvision.net.il
2-18-5
 
If your child's doctor or a child physiatrist diagnosis your child as suffering from ADD/ADHD - and recommends that you give your child Ritalin each morning before school in order to counter the negative effects of ADD/ADHD, then you should be aware of all the facts surrounding Ritalin. Instead of taking the advice of your doctor - or anyone else whether Ritalin is safe, simply read the packaging label Novartis puts inside each box of Ritalin. I did, and this is what it says:
 
Ritalin is a mild central nervous system stimulant. The mode of action in man is not completely understood, but Ritalin presumably activates the brain stem arousal system and cortex to produce its stimulant effect. There is neither specific evidence which clearly establishes the mechanism whereby Ritalin produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
 
Even the company can't verify that it is effective - or that it does what the user is told is says it does by our doctors. The company can also not guarantee that these drugs will not have a negative effect on the central nervous system of the user. In other words, in Novartis's own words- not enough research has been done to determine if Ritalin is safe- or if it is even effective.
 
Ask yourself this question: would you allow your child's foot to be x-rayed if the technician told you before the procedure that "we can't be 100% sure that the x-ray won't cause your child's foot to develop a deadly disease over time- and if this happens- we may have to amputate it"?
 
What if you picked up a chocolate bar in the supermarket and it said: "The manufactures of this product can't guarantee that by eating this chocolate bar a person won't suffer massive convulsions and die."? Would you buy it and give it to your child to eat?
 
The company that manufacturers Ritalin clearly states that they haven't investigate fully how these stimulants may interfere with the central nervous system of children? They are telling you in advance that these drugs have not been fully tested- nor are they guaranteed not to cause complications in the future- nor do they even know fully about the mechanisms that causes the change in mental and behavioral effects in the user.
 
The warnings continue:
 
Sufficient data on safety and efficacy of long-term use of Ritalin in children are not yet available.
 
By the company's own admission - the drug has not been tested sufficiently - and nobody can testify to the safety of this medication long term. One has to wonder that if the company who produces and markets these drugs isn't doing this research work to determine the long term effects of Ritalin usage- who will? Who has the ability and financial resources to ensure medicines approved for human consumption have no long term negative effects- other than the manufacturer?
 
So, if they say they haven't done this- shouldn't we believe them and not buy their product?
 
In the next line, we read:
 
Although a causal relationship has not been established, suppression of growth (i.e., weight gain, and/or height) has been reported with the long-term use of stimulants in children.
 
In the previous sentence Novartis claimed that they have not done any research on long-term use of Ritalin to determine if it is 100% safe. One sentence later - they claim that "a causal relationship" between suppression of growth (notice how they don't mention the growth of the child's brain - which one has to assume - from age seven on - is still in the process of growing?) has not been reported.
 
Perhaps Novartis has done long term research - but only revealed a part of their results - and not told us about the part of their research that questioned whether their products are safe for long term use?
 
The warning continues:
 
Clinical experience suggests that in psychotic children, administration of Ritalin may exacerbate symptoms of behavior disturbance and thought disorder. Safe concomitant use of anticonvulsants and Ritalin has not been established. Use cautiously in patients with hypertension. Blood pressure should be monitored at appropriate intervals in all patients taking Ritalin, especially those with hypertension.
 
In most cases- children are not tested for any of these disorders or medical conditions. So, despite the wide-spread claim by most of the medical establishment recommending Ritalin use that "Ritalin is completely safe" it appears the company that manufacturers the drug believes differently. It is clear from the list of potential dangers that this drug carries with it that the company has not done sufficient research on how these medications affect the body's central nervous system. If it did - it would not use words such as "may cause" and "has not been established". If blood pressure needs to be constantly monitored during Ritalin use - there is a danger of something- which Novartis probably knows- but has decided not to put on its warning labels.
 
Considering these warnings on the package, if Ritalin were being prescribed to a fully-grown adult- it would be cause enough for concern. But keep in mind we are talking here about a drug that is being given primarily to children from seven years old and up. Will these drugs adversely affect how the body organs in these children develop and grow? These drugs are supposedly supposed to counteract a chemical imbalance in the brain. Will they have any affect on how those brains grow and develop? Has Novartis investigated this so we know 100% for sure that they will not? Even if Novartis has tested them and was less than 100% convinced that they were completely safe- would they inform us about their concerns on their own package- or would they just use words such as "can cause" and "may have implications"?
 
Are you prepared to simply "not know" and hope these drugs are completely harmless for your children? The company which produces and sells these drugs has given the public plenty to be concerned about. Parents who take the decision to medicate their children with Ritalin should be equally concerned.
 
The Company isn't finished warning parents of what their products may do to their children (may do- they don't know because they haven't investigated the issue fully):
 
Human pharmacologic studies have shown that Ritalin may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systemically evaluated.
 
Not being a scientist I don't know what the implications of these warnings are- but they sound as if they are serious enough to warrant further investigation. Novartis certainly has or else they wouldn't have mentioned it on their packaging labels- probably so that they could not be sued for not informing the public of these potential drawbacks. However if most parents are like me - and aren't scientists - these words have absolutely no meaning. Yet it sounds like there are a lot of potential complications related to Ritalin use- and that the company is disclosing them- so that nobody can come back to them years later and say, "you never told us about these potential complications."
 
The instructions for use on the package then states:
 
Ritalin should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
 
Which I guess means that Ritalin and drug and alcohol abuse go hand in hand.
 
The label continues:
 
Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic over activity can be unmasked. Long-term follow-up may be required because of the patientís basic personality disturbances. Patients with an element of agitation may react adversely. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with Ritalin is usually not indicated. Long-term effects of Ritalin in children have not been well established.
 
At least the company is honest - and unlike your doctor who told you that the reason your child should be medicated with Ritalin is because he/she has a "chemical imbalance in the brain." Novartis recognizes that the drug is being given for "behavioral characteristics" - which cannot be confused with "chemical imbalances in the brain." They are also honest enough to inform us that they themselves have not investigated whether there are any long-term effects of Ritalin.
 
So despite the canard we hear from so many physicians and child psychiatrists who claim, "Ritalin is completely safe, don't worry" as least as far as Novartis knows - it isn't for long term use- simply because nobody has investigated if the drug is or is not safe when consumed over long periods of time.
 
Those are the unknown potential future side effects that could result from long term use. Here is what Novartis admits are the known side effects that occur the first day the drug is consumed:
 
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.
 
Notice how the issue of loss of appetite is right at the end of this list. This issue alone should have parents wondering if the drug is worth the benefit. For a young child not to eat during the school day ñ and to return home after not having eaten anything but was consumed before the drug was administered in the morning - means that child will not receive the nutrition and vitamins that food provides. If proper nutrition is not maintained- how can the brains and bodies of our children develop normally? If Ritalin retards their appetite- isn't that concern enough not to administer these drugs to small children?
 
Just so you understand what Novartis has told us, the Swiss multinational drug company has warned all parents that if you give your child Ritalin- the drug could cause your children to lose their hair, abdominal pains, nausea, liver damage, cerebral arthritis, dizziness, palpations, skin rash, fever, cardiac arrhythmia. hypersensitivity, urticaria, fever, anorexia; headache, blood pressure and pulse changes, and weight loss- not to mention anemia, a depressed mood, and insomnia.
 
That is quite a risk to take just so that the teacher won't call you at home and complain he can't sit still in class.
 
Joel Bainerman is a parent who recently took his child off Ritalin after learning of the potential dangers of this narcotic.



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