Expert: Eric Brandt - 9/20/2007

Question
QUESTION: I recently asked a question regarding a side effect of accutane.  The side effect I refer to is "premature closure of epiphysis".  I have sought at least 6 medical opinions regarding this.  All have been that this side effect is extremely rare and unlikely.

I am researching this subject as my 14 year old son is currently taking accutane.  It is a last resort after using several antibiotics and prescription creams for the past 2 years.  There is a concern about scarring as things have worsened.  His doctors and I agreed that the risk of growth plate closure is minimal but the risk of scarring is probable w/o the accutane.

Anyway, my question is:  how do the myriad of side effects get listed on the drug precaution sheet?  There are no percentages listed regarding how many people have experienced growth plate closure.  Is it because it is anecdotal stories or are there a lack of studies regarding this side effect?

I have searched for months for scientific studies on this subject.  All I can find are stories on the internet from random individuals saying they did not grow, and then I can also find stories from random individuals saying they did grow?

What is the best way to make a good decision on these side effects?

ANSWER: Hi Lor,
Here is what the manufacturer has to say about this topic.
Hyperostosis:  Due to possible occurrence of bone changes, a careful evaluation of the risk/benefit ratio should be carried out in every patient and isotretinoin administration should be restricted to severe cases of acne. In clinical trials of disorders of keratinization, with a mean dose of2.24mg/kg/day, a high prevalence of skeletal hyperostosis was noted. Two children showed x-ray findings suggestive of premature closure of the epiphysis. Additionally, skeletal hyperostosis was noted in 6of8patients in a prospective study of disorders of keratinization. Minimal skeletal hyperostosis has also been observed by x-rays in prospective studies of cystic acne patients treated with a single course of therapy at recommended doses.
The above was a quote from the product monograph.
As you already determined it is hard to nail them down for frequency of this side effect.
Other side effects they list do have numbers associated with them.
My sense is that this is not a common side effect. I have not heard of it from anyone I have had on this nedication.
My own son was on it for a short period and he is of average height for our family.
I think that if this is the last resort because all other measures were ineffecive and the scarring is disfiguring then try it at least for a short period. We chose a period when school was out (summertime) so if there were any side effects, they would not interfere with schooling.
Once we were satisfied things were going well we continued into the school year with no ill effects that interfered with school. Peeling of skin and dryness of lips is common.
Thank you for using Allexperts
Sincerely,
Eric Brandt, B.Sc. Pharm

---------- FOLLOW-UP ----------

QUESTION: Mr. Brandt,

Thank you for your quick and detailed reply.

Can I ask you how old your son was when he took accutane.  I sounds as though he experience and increase in height AFTER accutane usage?  What dosage was he on and for what length of time?  Did the acne recur?

With thanks!

Answer
Hi Lor,
He was started on it in the summer between grades 11 and 12. The acne did not recur. He took it for the duration of grade 12. Sorry I do not remember the dose but I do remember being initially alarmed because the dose was higher than usual but the dermatologist assured me that he had used this dose before safely on particularly difficult other cases.
Thank you for using Allexperts
Sincerely,
Eric Brandt, B.Sc. Pharm