Adverse drug reactions to first- and second-generation antidepressants: a critical evaluation of drug surveillance data.

We reviewed data on adverse drug reactions (ADRs) to first- and second-generation antidepressants, recorded by two different drug surveillance systems. The rate of ADRs that led to discontinuation of the drug in the individual case, assessed within a multi-centered hospital-based drug monitoring system (AMUP), was significantly higher in case of exposure to tricyclics (7.4%) than with the second-generation drugs (3.1%). On the basis of voluntary reports to the Medicines Commission of the German Medical Profession (AMK), profiles of ADRs to the drugs under survey were constructed and compared with data compiled by the WHO. The types of ADRs varied more between second-generation drugs than between tricyclics. Special attention was paid to rare but serious ADRs (e.g. seizures during treatment with maprotiline, and blood dyscrasias attributed to mianserin).