Reporting rates for severe hypersensitivity reactions associated with prescription-only drugs in outpatient treatment in Germany.
OBJECTIVE
To determine which 10 prescription-only drugs used in outpatient treatment in Germany are most frequently reported to induce severe drug hypersensitivity reactions taking into account their prescription numbers. In addition, the reader should be made aware of respective databases available to the public and their limitations.


METHODS
Reports of anaphylactic and severe cutaneous adverse reactions were identified in the adverse drug reaction database of the German competent authority for the time period January 1998 to December 2012. For frequently reported drugs, the total number of reports was matched with their total number of prescriptions resulting in the reporting rate.


RESULTS
Among the 10 drugs with the highest reporting rate for anaphylactic reactions, there were six antibiotics (moxifloxacin, levofloxacin, clindamycin, ciprofloxacin, cefuroxime and amoxicillin), three of which were fluoroquinolones. The other four drugs were glatiramer, metamizole and two angiotensin-converting-enzyme inhibitors. Concerning severe cutaneous adverse reactions, four out of ten drugs were antibiotics (clindamycin, sulfamethoxazol + trimethoprim, ciprofloxacin and amoxicillin), and three were anticonvulsives. Because dental prescription numbers were not available to the public, the real reporting rates for clindamycin and to a lesser extent for amoxicillin are presumably lower.


CONCLUSIONS
The predominance of antibiotics among the reports of severe immediate and delayed-type drug hypersensitivity reactions is largely in accordance with literature although fluoroquinolones seem to be slightly overrepresented concerning anaphylactic reactions. The reader should be aware of the limitations of adverse drug reaction and prescription databases available to the public, and that over-the-counter drugs, such as non-steroidal anti-inflammatory drugs, and drugs typically administered in hospitals could not be considered.
Federal Institute for Drugs and Medical Devices, Bonn, Germany.|Department of Dermatology and Allergology, University Hospital, RWTH Aachen, Aachen, Germany.
Bernhardt
B
Sachs
Federal Institute for Drugs and Medical Devices, Bonn, Germany.
Wilma
W
Fischer-Barth
Department of Dermatology and Allergology, University Hospital, RWTH Aachen, Aachen, Germany.
Hans Friedrich
HF
Merk
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000553:Ambulatory Care / Q000706:statistics & numerical data*; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D005858:Germany / Q000453:epidemiology; D006801:Humans; D006968:Hypersensitivity, Delayed / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D006969:Hypersensitivity, Immediate / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology; D017891:Pharmacoepidemiology; D055553:Prescription Drugs / Q000009:adverse effects*; D012720:Severity of Illness Index
D055553:Prescription Drugs
anaphylactic reactions; drug hypersensitivity; pharmacoepidemiology; reporting rates; severe cutaneous drug reactions