Drug-induced erectile dysfunction: an adverse effect under-reported in pharmacovigilance

摘要

Some drugs can induce erectile dysfunction (priapism or impotence) due to their pharmacological properties. Some adverse effects (ADRs) are only detected after marketing of the drug with a low frequency (unexpected ADRs). Pharmacovigilance and pharmacoepidemiologic studies collect data about real drug use and contribute to a better evaluation of the benefit/risk ratio. Data about cases of erectile dysfunction spontaneously reported to the French Pharmacovigilance system were collected over a 5-year period (2000 to 2004). 39 cases of drug-induced priapism were identified, 25 of which were classified as serious (62.5), mainly due to anticoagulants (12 cases), psychotropic drugs (8 cases), phosphodiesterase inhibitors (8 cases) and beta-blockers (2 cases). During the same period, 214 cases of impotence either isolated or associated with ejaculation dysfunction were reported, mainly with antiretroviral drugs, fibrates and HMG CoA reductase inhibitors, psychotropic drugs and beta-blockers. Our data indicate that some ADRs, such as erectile dysfunction, are severely under-reported. Spontaneous reporting and pharmacoepidemiologic studies could contribute to a better knowledge of drugs and their rational use.