Cylert (Pemoline) Side Effects

from the PHYSICIAN'S DESK REFERENCE®

CYLERT® Tablets [ci'lert] (Pemoline)

CLINICAL PHARMACOLOGY
CYLERT (pemoline) has a pharmacological activity similar to that of other known central nervous system stimulants; however, it has minimal sympathomimetic effects. Although studies indicate that pemoline (CYLERT) may act in animals through dopaminergic mechanisims, the exact mechanism and site of action of the drug in man is not known.

There is neither specific evidence which clearly establishes the mechanism whereby CYLERT produces its mental and behavorial effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

WARNINGS
Decrements in the predicted growth (i.e., weight gain and/or height) rate have been reported with the long term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored.

PRECAUTIONS
General: Clinical experience suggests that in psychotic children, administration of CYLERT may exacerbate symptoms of behavior disturbance and thought disorder.

CYLERT should be administered with caution to patients with significantly impaired renal function.

Laboratory Tests: Liver function test should be performed prior to and periodically during therapy with CYLERT. The drug should be discontinued if abnormalities are revealed and confirmed by follow-up tests. (See "ADVERSE REACTIONS" section regarding reports of abnormal liver function tests, hepatitis and jaundice.)

Pediatric Use: Safety and effectiveness in children below the age of 6 years have not been established.

Long-term effects of CYLERT in children have not been established (See "WARNINGS" section).

CNS stimulants, including pemoline (CYLERT), have been reported to precipitate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourettte's syndrome in children and their families should precede use of stimulant medications.

Drug treatment is not indicated in all cases of ADD with hyperactivity and should be considered only in light of complete history and evaluation of the child. The decision to prescribe CYLERT (pemoline) should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more the behavioral characteristics.

ADVERSE REACTIONS
The following are adverse reactions in decreasing order of severity within each category associated with CYLERT:

Hepatic: There have been reports of hepatic dysfunction including elevated liver enzymes, hepatitis and jaundice in patients taking CYLERT.

Hematopoietic: There have been isolated reports of aplastic anemia.

Miscellaneous: Supression of growth has been reported with the long-term use of stimulants in children. (See "WARNINGS" section.) Skin rash has been reported with CYLERT.

Central Nervous System: The following CNS effects have been reported with the use of CYLERT: convulsive seizures; literature reports indicate that CYLERT may precipitate attacks of Gilles de la Tourette syndrome; hallucinations; dyskinetic movements of the tongue, lips, face and extremities; abnormal oculomotor function including nystagmus and oculogyric crisis; mild depression; dizziness; increased irritability; headache; and drowsiness.

Insomnia is the most frequently reported side effect of CYLERT; it usually occurs early in therapy prior to an optimum therapeutic response. In the majority of cases it is transient in nature or responds to a reduction in dosage.

Gastrointestinal: Anorexia and weight loss may occur during the first weeks of therapy. In the majority of cases it is transient in nature; weight gain usually resumes within three to six months.

Nausea and stomach ache have also been reported.

DRUG ABUSE AND DEPENDENCE
Controlled Substance: CYLERT is subject to control under DEA schedule IV.

an excerpt from The Essential Guide to Psychiatric Drugs

STIMULANT ANTIDEPRESSANT DRUGS
Depression may also be treated with drugs called psychostimulants. Use of such drugs is reserved for only two situations: (1) patients who have failed to respond to at least two other antidepressants and psychotherapy and who are seriously depressed, and (2) patients with serious and usually terminal medical illnesses such as cancer or AIDS who are depressed and too sick to take other kinds of antidepressants.

The reason for these restrictions is that the stimulant drugs are addictive. They include amphetamines, sometimes called "speed" or "uppers," methylphenidate (Ritalin), and pemoline (Cylert). The drugs produce a short-term mood elevation even in people who are not depressed. College students take them to stay awake ail night and finish term papers.

In most people the effects of these stimulant drugs are short-lived and there is often a letdown or "crash" after they wear off. During this "crash" the patient can feel very depressed, sleepy, and sluggish. Furthermore, and very much unlike the other drugs discussed so far in this chapter, stimulant drugs have the potential to induce "tolerance." People who abuse amphetamines and other stimulants--usually in attempts to lose weight or stay awake for prolonged periods--often find that a dose that had worked for a while is suddenly ineffective and they need a higher dose. They then become "tolerant" to the higher dose and have to increase the dose again. Soon, the person is addicted to the drug. Stopping it suddenly leads to a severe withdrawal reaction characterized by bad depression and extreme fatigue. Suicides have been reported in people who suddenly stop taking amphetamines.

Given all these problems, why even mention the stimulant drugs? Simply because they are the only drugs that work for some depressed patients. A very small group of usually chronically depressed patients seems to be resistant to every other treatment for depression. These people usually function at a fairly low level relative to their ability and they feel sad and blue all of the time. They complain of fatigue, low interest in life, and inability to concentrate. Many say they have been depressed since childhood.

Another small group of patients with very serious medical problems also develops depression. Sometimes the medical problems they have make other antidepressant drugs unsafe, or the medical problems so magnify the side effects of the other antidepressants that the dying patient is made even more uncomfortable. Stimulant drugs may actually be the safest choice in this situation.

For these two groups of patients stimulant drugs may be the only answer, even though the patient will probably become addicted. This is not to be taken lightly. The decision to place a patient on a stimulant drug for depression is serious and must be done only after all other efforts are declared either unsafe or ineffective. The patient must understand that he will probably become addicted to the medication and that he should never stop taking it abruptly.

an excerpt
"The People's Pharmacy" Avon Books, and St. Martin's Press (1976)

Some health professionals fear that these medications may end up being over prescribed. Dr. Carl Kline, an expert in the field of learning disabilities from the University of British Columbia, has this to say, 'It is my belief that if these drugs were outlawed, children would not be at all deprived of essential medication, but that doctors would be forced to make more accurate diagnoses and seek better means of handling the hyperactive behavior of a certain small percentage of their little patients.'"

Do these drugs make a difference in the long-term outcome of the minimal brain dysfunction? The above referenced book goes on to say...

Until recently, the most important question concerning Ritalin or Amphetamine administration has not been asked. Do these drugs make a difference in the long-term outcome of the minimal brain dysfunction? A comprehensive examination of this subject carried out at the Montreal Children's Hospital discovered a startling fact. At the end of five years, hyperkinetic children who received drugs (either Ritalin or Chloropromazine) did not differ significantly from children who had not received. Although it appeared that hyperactive kids treated with Ritalin were initially more manageable, the degree of improvement and emotional adjustment was essentially identical at the end of five years to that seen in a group of kids who had received no medication at all.

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