Is tinnitus a reversible or irreversible side-effect during treatment with paroxetine?/nIs it bene

Fråga: "Is tinnitus a reversible or irreversible side-effect during treatment with paroxetine? Is it beneficial to change from paroxetine to Cipramil (citalopram) considering the risk for tinnitus? A 39-year-old woman, with hearing damage since she was born, has been treated with Seroxat (paroxetine) 20 mg for 12 days due to depression. Since the beginning of Seroxat treatment she has noticed "ringing" in one ear several times. Paroxetine is known to give rise to tinnitus. However, according to the Swedish catalog of approved medical products (FASS) tinnitus is an uncommon side-effect of Seroxat."

Sammanfattning: Tinnitus seems to be an uncommon side-effect of antidepressants. There have been reports that tinnitus did not disappear for a long time after discontinuation of the antidepressants, including paroxetine. Although tinnitus is not mentioned as a side-effect of citalopram in FASS, there have been several reported cases of this side-effect associated with citalopram and the symptom remained for a long time after the drug treatment was discontinued.

Svar: Questions on tinnitus associated with antidepressive treatment have been dealt with previously in Drugline (1-3). In summary, tinnitus is an uncommon side-effect of antidepressants. The mechanism is not clear. In some cases the tinnitus has disappeared or been relieved after dose-reduction. However, there have been cases where the tinnitus did not disappear 12 months after drug discontinuation (1-3).

Eight cases of tinnitus associated with Seroxat have been reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC) where the causal relation was judged possible: Four of the cases showed a positive de-challenge; in three of the cases the tinnitus did not disappear when the cases were reported up to 6 months after the drug discontinuation; in one case the tinnitus disappeared although drug treatment was not discontinued (4).

Tinnitus is not listed in FASS (the Swedish physicians reference) as a side-effect of Cipramil although it is listed as an uncommon side-effect of SSRIs such as Seroxat and Fevarin (fluvoxamin). Six cases of tinnitus have been reported to SADRAC associated with citalopram: three cases with positive de-challenge and three cases with negative de-challenge (the patients still had tinnitus when the cases were reported up to 9 months after onset of the symptom).

An updated Medline search did not find any reports on tinnitus associated with paroxetine or citalopram treatment. Manufacturers of Seroxat and Cipramil have been contacted, but no further information was provided.