The question concerns a patient treated with isotretinoin (Roaccutan) more than five years ago. Dur

Fråga: The question concerns a patient treated with isotretinoin (Roaccutan) more than five years ago. During treatment the patient developed adverse effects such as prickling sensation in the skin, dizziness and later hypersensitivity to sound and swallow disorder. Investigation has showed pathological audiometry and pathological videometry of the oesophagus peristaltic. Is there any documentation of these neurological side-effects and isotretinoin?

Sammanfattning: Both central and peripheral neurological side-effects are rare but well documented for isotretinoin. The adverse effects are usually reversible following discontinuation of therapy. However, there are some cases of neurological side-effect reported to the department of Drug Safety of the manufacturer (Roche), that were not considered reversible. No specific documentation could be found concerning isotretinoin, hypersensitivity to sound and swallow disorder.

Svar: Isotretinoin, or 13-cis-retinoic acid, is a licensed agent used by dermatologists for the treatment of severe acne. Adverse reactions are generally dose related and are usually reversible on dose reduction or discontinuation of therapy (1). Adverse effects upon the central and peripheral nervous system are rare but well documented. The data files of Swedish Adverse Drug Reactions Advisory Committee (SADRAC) contain seven cases of neurological side-effects. Four cases of headache, which is the most commonly reported neurological side-effect, are found in the literature. Other side-effects reported were convulsions, paraesthesia and muscle weakness (2). Other neurological side-effects are reported, such as drowsiness, nausea and vomiting, peripheral neuropathy and mild psychological disorders. Some of these cases are reported not to be reversible when treatment was discontinued (3).

Rarely, pseudotumor cerebri or benign intracranial hypertension may occur (4). Symptoms associated with this condition are headache, loss of concentration, nausea and vomiting, drowsiness and impaired vision. Patients presenting with these symptoms are recommended to be screened for papillary oedema. Patients on tetracyclines are at increased risk because tetracycline may also uncommonly produce this condition (5). We could not find any specific documentation on isotretinoin and hypersensitivity to sound and swallow disorder. The present case should be reported to SADRAC.