[Adverse effects of locally applied drugs]

Topical drugs, such as non-steroidal anti-inflammatory drugs (NSAIDs), are available without prescription and are widely used for moderate, acute and chronic painful conditions. However, the different characteristics of their adverse reactions remain largely unknown. The present work was undertaken in order to quantify ADRs reported to our centre with topical drugs during a period of 5 years. The retrospective study was performed using the spontaneous reports to the Midi-Pyrénées Pharmacovigilance Centre from 1993 to 1997. The following routes of administration were selected: cutaneous, ocular, pulmonary, vaginal, intra-articular, auricular, nasal, buccal and pharyngeal. One hundred and twenty-eight notifications were found in the database. Thirty-eight cases (29.7 per cent) were between 60 and 75 years old, 25 cases (19.5 per cent) between 45 and 60 years old and 22 cases (17.2 per cent) between 30 and 45 years old. The most frequently reported ADRs were cutaneous (n = 71, 55.5 per cent) cardiovascular (n = 16, 12.5 per cent), ocular (n = 13, 10.2 per cent), neurological (n = 12, 9.4 per cent) and oro-pharyngeal (n = 7, 5.4 per cent). Systemic ADRs (45 cases, 35 per cent) occurred mainly with aerosols (n = 10) and patches (n = 6). Twenty-seven reports (21 per cent) were classified as 'serious' including one death (misuse). The main pharmacotherapeutic agents involved were rheumatological [(n = 29) including 20 NSAIDs], dermatological (n = 27), ophthalmological (n = 16), pneumological (n = 15) and cardiovascular (n = 15) drugs. In 21 cases the rechallenge was positive. In eight cases (6.3 per cent), ADRs occurred after self-medication. This study underlines the importance of monitoring ADRs of topical drugs. The seriousness of such ADRs and the occurrence of systemic effects with such drugs seems rather frequent (as shown by topical NSAIDs-induced photosensitization).