To evaluate the association between intracranial hypertension (IH) and isotretinoin use.
Design
Observational case series.
Methods
In this retrospective study, approximately 1950 case reports of adverse ocular side effects related to isotretinoin were received from spontaneous reporting systems. Reports were evaluated as to the occurrence of IH with isotretinoin use. A survey was mailed to all members of the North American Neuro-ophthalmology Society soliciting their opinions on whether isotretinoin caused IH.
Results
One hundred seventy-nine reports of IH were associated with isotretinoin use. The mean time from drug exposure to IH diagnosis was 2.3 months. There were 6 cases of positive rechallenge; 5 new cases are reported here, along with 1 previously published report. Of neuro-ophthalmologists surveyed (62% response rate), 6% believed an association between IH and isotretinoin use was certain; 32%, probable; 52%, possible; and 10%, unlikely. Twelve respondents (4%) had personally seen one or more cases of positive rechallenge with isotretinoin causing IH.
Conclusions
Based on the number and pattern of rapid IH onsets after isotretinoin exposure and the 6 cases of positive rechallenge, along with the probable similarity in metabolic pathways of this agent and vitamin A (a known cause of IH), it seems certain that there is a direct correlation between IH and isotretinoin use.
1Casey Eye Institute, Oregon Health & Science University, Portland, Oregon, USA
2University of Mississippi School of Medicine Neurology Department, Jackson, Mississippi, USA
3Collaborating Center for International Drug Monitoring, World Health Organization, Uppsala, Sweden
4National Registry of Drug Induced Ocular Side Effects, Casey Eye Institute, Portland, Oregon, USA
Reprint requests to F. W. Fraunfelder, MD, Casey Eye Institute, 3375 SW Terwilliger Boulevard, Portland, OR 97239-4197, USA.
The authors are indebted to the national centers mentioned in this study that contributed data. The opinions and conclusions, however, are not necessarily those of the various centers or of the World Health Organization. The authors have no proprietary interest in these materials.
This study was supported in part by an unrestricted grant from Research to Prevent Blindness, New York, New York.
ABSTRACT