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13 Ellul 5762 - August 21, 2002 | Mordecai Plaut, director Published Weekly
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Home and Family
PREPARING FOR THE FUTURE
Background to Methylphenidate (Ritalin)

by R' Zvi Zobin

The National Institute for Clinical Excellence (NICE) is a part of the British National Health Service. Its purpose is to provide practical guidance for the NHS and patients on medicines, medical equipment, diagnostic tests and clinical and surgical procedure, and where and how they should be used.

Each of these guidelines takes around twelve months to formulate and they consult the manufacturers of the drug or device, the professional organizations and the groups which represent patients.

Methylphenidate (Ritalin and Equasym) is licensed for use in the treatment of children with ADHD and is a Schedule 2 controlled drug.

Sale and use of the drug needs to be controlled because it is of the same type as drugs such as amphetamine and cocaine. These drugs achieve their effect by interacting with the pharmacology of the central nervous system (the brain and spinal cord) and altering its functioning. Apart from the danger of their immediate effects, all drugs in this Schedule 2 group can cause long-lasting effects and become addictive. In some ways, methylphenidate has been found to be even more powerful than cocaine.

The license for these products specifies that methylphenidate should only be used as a part of a comprehensive treatment program when remedial measures alone prove insufficient. They propose that a `comprehensive treatment program' include psychological, educational and social measures. It also states that methylphenidate should only be prescribed for severe cases of ADHD following detailed history taking and evaluation.

This means that it would be irresponsible for someone to tell parents to ask their local family doctor to prescribe Ritalin "just to see if it helps." Giving someone a drug of the power of a methylphenidate is a serious step only to be taken as a last resort and only when all the necessary conditions have been fulfilled.

It is not currently recommended by the Summary of Product Characteristics (SPC) nor licensed for use in the U.K. for children less than six years of age because its safety for use on children less than six years of age has not been determined.

Methylphenidate is not currently recommended by the Summary of Product Characteristics (SPC) nor licensed in the U.K. for children with marked anxiety, agitation or tension; symptoms or family history of tics or Tourette's syndrome; hyperthyroidism; severe angina or cardiac arrythmia; glaucoma or thyrotoxicosis.

Caution is also required in the prescribing of methylphenidate for children and young people with epilepsy, psychotic disorders or a history of drug or alcohol dependence.

The drug is relevant to epilepsy because there is some clinical evidence that methylphenidate may lower the convulsive threshold in patients with prior history of seizures, with prior EEG abnormalities in absence of seizures and, very rarely, in patients with no prior EEG evidence nor history of seizures.

NICE recommend that treatment with methylphenidate should only be started by a child-and-adolescent psychiatrist, or a pediatrician with expertise in ADHD. Prescribing of the drug and monitoring of the patient may be performed by a GP, but only under shared care arrangements with the specialists.

As they note, not everyone who is overly hyperactive, inattentive, or impulsive has an attention disorder. Their guidelines to the specialists are that he must also consider that the following are present to diagnose ADHD:

* The signs have persisted for at least six months to a degree that is impairing the child's development;

* There must be clear evidence of clinically significant impairment in social or academic functioning;

* Some impairment is present in two or more settings (usually at home and at school);

* Some of the signs that caused impairment were present before the age of seven;

* The signs do not occur exclusively during the course of a pervasive developmental disorder, schizophrenia or other psychotic disorder and are not better accounted for by other mental disorders such as depression or anxiety.

Many factors can cause a child to feel anxiety, such as pressure from parents to keep up with a stressful school curriculum, tests, peer competition and/or sibling competition and problems with vision and/or auditory processing. In such circumstances, NICE recommend that medication is not to be attempted but instead to deal with the core problem.

As is well known, many other factors can cause ADHD- like problems. For example, a gifted, creative child can have many of the characteristics of ADD or ADHD.

NICE also note that dietary interventions are seen as possibly useful in cases where a parent has observed that a particular food aggravates hyperactivity. Parents can use the `four-day diet' to see if particular foods are contributing to a person's hyperactivity. Foods commonly causing hyperactivity include sugar, colors and preservatives, soy, milk and milk products, chocolate, wheat, oranges and eggs.

If the drug is finally prescribed and improvement of symptoms is not observed after appropriate dose adjustment over one month, NICE recommend that the drug be discontinued. They suggest that methylphenidate should be discontinu-ed periodically (under careful supervision) to access the child's condition. Although no firm guidelines for withdrawal of treatment are given, they note that drug treatment should usually be discontinued during adolescence. Discontinuance of the drug must be performed carefully and under guidance because, as stated in the DSM-III, there can be severe withdrawal symptoms such as depression and a tendency to suicide.

NICE quote the recommendation of the Summary of Product Characteristics (SPC) that blood pressure be monitored, particularly for patients with hypertension. This is because as a stimulant of the central nervous system, the drug's side effects include increased blood pressure and increased heart rate. Therefore, the drug should not be given to someone who already suffers from high blood pressure.

According to the testimony of neurologist Fred. A Baughman Jr. MD, May 4, 2000, before the Health Services subcommittee of the U.S. House and Senate Committees on Public Health, Welfare and Labor, of the 2,993 adverse reactions to Ritalin reported to the FDA from 1990 to 1997, there were 160 deaths and 69 hospitalizations. 126 of these adverse reactions were cardiovascular.

One of the most widely reported cases was the death of Matthew Smith, a 14-year-old American boy, on March 2000, while skateboarding. His death touched off a controversy as the police pathologist, Dr. Ljubisa Dragovic, in spite of pressure "to find some other explanation," announced that the boy's death was caused by heart damage from eight years of Ritalin use. At the autopsy, Dr. Dragovic found that Matthew's heart showed clear signs of small vessel damage of the type caused by stimulant drugs such as amphetamines and cocaine. The boy did not have a pre-existing heart defect or disease and he had not been taking any other drugs.

The SPC also recommend that patients on long-term therapy have periodic blood and platelet counts.

 

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