Does the oral preparation of omeprazole give the same type of adverse effect on the eyes as the par

Fråga: Does the oral preparation of omeprazole give the same type of adverse effect on the eyes as the parenteral preparation?

A 52-year old woman with hearing disorders, psychiatric disturbances, heart problems and photophobia is treated with clomipramine, a beta-blocker and omeprazole. Recently the dose of omeprazole was increased from 20 to 40 mg daily and the photophobia has worsened.

Sammanfattning: Reversible impaired vision has been reported in a few cases after oral treatment with omeprazole. The six cases reported of irreversible vision impairment in severly ill patients treated with intravenous high doses of omeprazole could probably be explained by the underlying disease.

Svar: Omeprazole has been suspected to cause ophthalmological adverse reactions in ten cases reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). These were, decreased vision in three cases, blurred vision in five cases, diplopia in one case and conjunctivitis in one case. All were judged to have a possible or probable causal relation to the drug treatment.

During the spring of 1994 a report to Germany´s Federal Health Agency (BGA) described 19 cases of visual disturbances in connection with omeprazole treatment (1). Six of these cases concerned severe irreversible visual impairment. All six cases appeared in severly ill patients given iv treatment. The remaining 13 cases refer to reversible impaired vision after oral intake.

An expert panel reviewed the cases and unanimously concluded that there was no reason whatsoever for suspecting oral or intravenous omeprazole as having a role in the alleged adverse events cited by BGA. The patients´ underlying disease with severe hypotension were the most probable cause of the visual impairment (2).

The Swedish Medical Product Agency has expressed a similar opinion (3).

In view of the millions treatment courses with omeprazole and the preclinical and clinical safety documentation, these observations are judged coincidental (2).

We have not found any information in the literature concerning photophobia and omeprazole treatment. 1 Schönhöfer PS: Intravenous omeprazole and blindness. Lancet 1994; 343: 665 2 Creutzfeldt WC, Blum AL: Safety of omeprazole. Lancet 1994; 343: 1098 3 Wiholm BE: Losec och rapporter om ögonskador i Tyskland. Pressrelease 1994 mars 8