Are blurred vision and other untoward eye disorders documented for esomeprazole (Nexium)?/nTreatmen

Fråga: Are blurred vision and other untoward eye disorders documented for esomeprazole (Nexium)?

Treatment with Nexium 40 mg/day was initiated for hyperacidity in a 51-year-old woman. Ten days later she complained of blurred vision. Nexium treatment was stopped and the symptoms disappeared three days thereafter. After another eight days, treatment with Pantoloc (pantoprazole) was initiated. It is unknown whether the adverse effect has reappeared.

The case has been reported to the regional adverse drug effect centre in Stockholm.

Sammanfattning: No reports of blurred vision or other ocular side effects associated with esomeprazole have been found in available literature. However, blurred vision or other ocular side effects have in a small number of cases been reported in association with omeprazole and other proton pump inhibitors. Although there is limited knowledge of ocular safety for esomeprazole, an adverse effect profile similar to that of omeprazole is expected.

Svar: Esomeprazole is the S-enantiomer, which is the most potent enantiomer, of omeprazole racemate (1). No case of blurred vision or other untoward eye disorders associated with esomeprazole has been found in the literature. However, esomeprazole has not been on the market for long.

Ocular side effects associated with omeprazole or other proton pump inhibitors have been discussed previously in Drugline (2,3) as well as in other sources (2-6). However, it has been debated whether or not omeprazole treatment increases the risk of suffering from ocular side effects. In particular, a series cases of blindness during treatment with omeprazole, especially after intravenous administration, has been a subject of discussions (6-9). No conclusive data has been published. In a cohort study 341 medical records of vascular lesions of the eye was reviewed and 58 cases met the inclusion criteria for the final analysis. A major increased risk for eye associated complications after treatment with omeprazole or other anti-ulcer agents could not be confirmed (5).

In the Swedish adverse drug reactions registry (Swedis) there are seven reports of blurred vision, three of abnormal vision, one decreased vision and one case of abnormal accommodation possibly related to omeprazole treatment and one vision blurred possible related to lansoprazole treatment (10).

Omeprazole is metabolised by the polymorphic cytochrome P-450 isoenzyme CYP2C19. Therefore, being a poor metaboliser of CYP2C19 might be a possible risk factor to develop ocular side effects. However, this could not be shown in 29 omeprazole treated patients who developed visual disorders (11).

Although there is limited knowledge about ocular safety for esomeprazole, a similar adverse effect profile, compared to omeprazole is expected.