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Stevens‐Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): Evaluation for drug risk based on sale numbers in defined daily doses (DDD). Example of the H 2 ‐antagonists
Author(s) -
Rzany Berthold,
Mockenhaupt Maja,
Holländer Norbert,
Stocker Ulrich,
Mueller Judit,
Baur Susan,
Schöpf Erwin
Publication year - 1995
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2630040403
Subject(s) - medicine , famotidine , ranitidine , toxic epidermal necrolysis , cimetidine , phenytoin , incidence (geometry) , drug , pharmacoepidemiology , medical prescription , dermatology , anesthesia , epilepsy , pharmacology , physics , psychiatry , optics
We report on the results of the registration of SJS, SJS/TEN overlap and TEN with maculae in West‐Germany and Berlin from 01.04.90 to 31.12.92. The results are based on the ‘Dokumentationszentrum schwerer Hautreaktionen’, a registry on severe skin reactions, which regularly contacts more than 1500 hospitals (departments of dermatology, departments of pediatrics, burn units and internal medicine departments with intensive care facilities). With a response rate ranking from 77% to 95% over a period of 33 months 270 cases of SJS, SJS/TEN overlap and TEN have been included into the registry. More than 1690 single drugs had been taken two weeks prior to the skin reaction. Among those drugs ranitidine was found in 25 patients. Other H 2 ‐antagonists were taken in 12 cases (famotidine in 11 cases and cimetidine in one case). Evaluation of drug risk incidences for these drugs were calculated based on prescription data in defined daily doses (DDD), which were obtained from the ‘Wissenschaftliches Institut der Ortskrankenkassen’ (WIDO), Heidelberg, Germany. For ranitidine incidences of 0.19, 0.14, 0.10 could be evaluated, compared to 0.11, 0.29 for famotidine and 0.06 for cimetidine for 1990, 1991 and 1992, respectively. Over the observation period the incidences for ranitidine were stable in contrast to famotidine. As probable confounding factors co‐medication with phenytoin, dexamethasone, heparin and, in addition, concomitant illnesses as brain‐tumours and cerebral metastasis could be found. The example of the H 2 ‐antagonists shows that incidence data should be interpreted cautiously. To avoid misinterpretation incidences should be observed over a period of several years, and in every case confounding factors should be taken into account.