Anaphylaxis and toxic epidermal necrolysis or Stevens–Johnson syndrome after nonmucosal topical drug application: fact or fiction?
B. Sachs
Division of Pharmacovigilance, Federal Institute for Drugs and Medical Devices, Bonn, Germany
Department for Allergology and Dermatology, RWTH Aachen University Hospital, Aachen, Germany
Search for more papers by this authorW. Fischer-Barth
Division of Pharmacovigilance, Federal Institute for Drugs and Medical Devices, Bonn, Germany
Search for more papers by this authorS. Erdmann
Department for Allergology and Dermatology, RWTH Aachen University Hospital, Aachen, Germany
Search for more papers by this authorH. F. Merk
Department for Allergology and Dermatology, RWTH Aachen University Hospital, Aachen, Germany
Search for more papers by this authorJ. Seebeck
Division of Pharmacovigilance, Federal Institute for Drugs and Medical Devices, Bonn, Germany
Search for more papers by this authorB. Sachs
Division of Pharmacovigilance, Federal Institute for Drugs and Medical Devices, Bonn, Germany
Department for Allergology and Dermatology, RWTH Aachen University Hospital, Aachen, Germany
Search for more papers by this authorW. Fischer-Barth
Division of Pharmacovigilance, Federal Institute for Drugs and Medical Devices, Bonn, Germany
Search for more papers by this authorS. Erdmann
Department for Allergology and Dermatology, RWTH Aachen University Hospital, Aachen, Germany
Search for more papers by this authorH. F. Merk
Department for Allergology and Dermatology, RWTH Aachen University Hospital, Aachen, Germany
Search for more papers by this authorJ. Seebeck
Division of Pharmacovigilance, Federal Institute for Drugs and Medical Devices, Bonn, Germany
Search for more papers by this authorAbstract
Background: Drug-induced anaphylaxis and toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome (SJS) represent severe immediate and delayed-type adverse drug reactions (ADRs), respectively. Occurrence of such reactions after topical drug application has only rarely been reported. Hence, we compiled a large number of such cases which we systematically analyzed.
Methods: All such cases contained in the ADR database of the competent pharmacovigilance authority in Germany and cases reported in literature were identified, evaluated and analyzed with regard to potential risk factors. Since the application of drugs to mucous membranes facilitates their entry to the systemic circulation only cases occurring after non-mucosal topical drug application were considered.
Results: After evaluation 28 anaphylaxis database cases and 48 anaphylaxis literature cases remained for analysis. Application to skin wounds or to skin with impaired barrier function was identified as a risk factor in 10/28 (36%) of the database cases and in 42/48 (88%) of the literature cases. In 9/28 database cases (32%), anaphylaxis was induced by drugs used for their hyperemizing effect and, in 8/28 cases (29%) by antibiotics or antiseptics. In the literature cases, anaphylaxis was induced by antibiotics or antiseptics in 35/48 cases (73%). Only one SJS database case and one TEN literature case remained after case evaluation.
Conclusion: Anaphylaxis does occur after non-mucosal topical drug administration. Application of drugs to skin wounds or to skin with impaired barrier function may pose a risk factor for its occurrence. TEN or SJS following non-mucosal topical drug application seems to be extremely rare.
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