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Medifocus Guidebook on
Peripheral Neuropathy
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At What Point Does the Risk of Taking a Medicine Outweigh the Benefit? 
A few years ago one of my patients went to see a cardiologist who prescribed atenolol as a precaution due to some degree of labile hypertension noted during the examination. The patient didn't really have any obvious symptoms, but the risk of a future heart attack or stroke was present. However, the medication caused the patient to feel sleepy during the day and he found it difficult to perform his work. Fortunately he was not engaged in working with heavy machinery. Then, several days later, he fell asleep while driving, awakened just in time by ridges on the highway shoulder. It suddenly occurred to him that he preferred to risk a heart attack or stroke some years in the future to being killed or maimed in an automobile accident. Fortunately adjusting the dose to one half strength provided a fair measure of control. There was still some sleepiness, but after a while that disappeared. This patient was lucky. However, many others have not been so fortunate. The list of side effects caused by some drugs can be so lengthy and scary that it can actually seem ridiculously funny, especially when a pharmaceutical company attempts to tout some new pill on TV. Obliged to mention side effects the presentation is a bit like the small print used by a loan company. A gentle-voiced woman might be utilized, for example, to rapidly go through the list in such a sweet sounding tone as to imply that these symptoms are not really important or likely to ever occur. I have heard some commercials urging a patient to speak to his or her doctor in which the side effects actually sounded as if they were beneficial.
Sometimes the decision as to whether the risk of taking a medicine outweighs the benefit can become more than just a simple positive versus negative compilation. This is especially true when dealing with potentially dangerous medications for cosmetic purposes. We have discussed the use of botulinum toxin for wrinkles previously. The positives and negatives in this instance are relatively simple since the final decision depends on the degree of narcissism involved. Obviously there are exceptions here as well. When an individual's career may hinge on facial appearance the risk versus benefit ratio diminishes considerably.
Perhaps one of the most glaring examples of the difficulty involved in deciding whether to take a dangerous medication is seen with the use of isotretinoin (Accutane®) for treating severe recalcitrant nodular (cystic) acne. The disease, when untreated, can be quite disfiguring, but the worst aspect of this tragic condition is that it attacks the young during puberty and can last for many years. The effect can be devastating; occasionally leading to attempted suicide. Given the choice between a potentially dangerous medication and disfigurement it is the rare young adolescent who will not prefer to take the risk of side effects. Some of the side effects may be considered to be tolerable. In recent years such minor problems like warts or inflammation of the lips (cheilitis) have been recorded. When I reported a case of persistent cheilitis several years ago the company, Roche Laboratories, had never heard of this complication. Since then more cases have surfaced and it is well recognized that simple non-persistent cheilitis occurs in over 90% of patients. But these lesser possibilities, including musculoskeletal problems such as arthralgia, or perhaps chest pain, are only at the tip of the iceberg.
Numerous other dangerous complications may occur. Corneal opacities and cataracts are probably the most damaging. During development of the embryo the skin and nervous system arise from the same tissues. Therefore one would presume that medication with potent effect on the skin might also affect the central nervous system. Reports of seizures, emotional instability, dizziness, nervousness, drowsiness, malaise, weakness, insomnia, lethargy, and paresthesias are mentioned in the Physicians' Desk Reference (PDR) as possibly having no true relationship. Nevertheless, pseudotumor cerebri has been definitely acknowledged to be related. Some cases occurred when taking tetracyclines simultaneously. It gets worse. The PDR mentions that a "number of patients treated with Accutane have reported depression, psychosis, rarely suicidal ideation, suicide attempts and suicide." Stopping treatment seems to stop the symptoms. This is an interesting paradox. We have young people with a horribly disfiguring disease who might be prone to considering suicide taking a medication that markedly improves their appearance, but may lead them to consider or even attempt suicide. Does this really happen? Jick and colleagues tackled this question in an article called "Isotretinoin Use and Risk of Depression, Psychotic Symptoms, Suicide, and Attempted Suicide" which they published in volume 136 of the Archives of Dermatology during 2000. Analyzing data from the Canadian Saskatchewan Health Database and the United Kingdom General Practice Research Database they concluded that there was no association between use of the drug and these side effects. This might be considered to be rather encouraging except for one minor little discrepancy. The study was funded by F. Hoffman-La Roche Ltd. the producers of Accutane®.
Then there's another serious aspect to using this drug. It's a notorious teratogen. In other words, babies born to pregnant women taking isotretinoin may end up malformed. Anyone prescribing the drug must be fully aware of this probability and take appropriate precautions. Nevertheless, in today's atmosphere of sexual promiscuity, the risk remains extremely problematic. Given this ability to markedly affect the fetus, one must obviously take into consideration the possibility of as yet undiscovered serious damage to adult human organs. On November 1 of 2002 Roche Laboratories and the U.S. Food and Drug Administration extensively revised the safety labeling for isotretinoin. Warnings were issued for psychiatric disorders, and to pediatric patients, and a new table was devised to clarify when pregnancy tests and Accutane Qualification stickers are needed. Pediatric patients were alerted to the risk of sport fractures, spondylolisthesis with and without pars fractures, and hip growth plate injuries. As many as 29% of these children developed back pain and 22% experienced arthralgias.
Even Roche and the FDA seem to be worried. Soon Roche, losing it's patent protection, feared replacement by several generic companies eager to get their hands on the profits inherent in producing isotretinoin. One company responded quickly by preparing a large advertising campaign to physicians utilizing their current area representatives. How safe will these new copycat drugs be? Are you willing to take these risks for yourself or your children or do you prefer to risk varying degrees of disfigurement from the disease?
Johnny was a handsome boy,
Destined to bring his parents joy,
Then one day the tables turned,
Fate brought John lessons to learn.
Terrible sores marred his face,
And scars appeared to take their place,
Then handsome Johnny was no more,
His confidence shaken to the core.
Johnny soon became depressed,
"I think about dying," he confessed,
But a wonderful cure came upon the scene,
And lo and behold his face was clean.
Then Johnny again became depressed,
"I think about dying," he confessed,
Johnny now lies beneath the ground,
And upon his gravestone can be found,
"Here lies Johnny, a handsome boy,
Done in by that which brought him joy."
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Cartoons and Poems following each article are created and copyrighted by Dr. Ackerman and cannot be copied or reproduced without his permission.
Copyright © 2006 by Marvin Ackerman, M.D.
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