Hypersensitivity to Generic Drugs with Soybean Oil

The authors report on two women who presented with anaphylaxis a few minutes after ingesting a generic omeprazole capsule. The generic drug that each of the women took contained approved soybean oil as an excipient. To the Editor: The use of generic drugs has increased in the European Union in recen...

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Veröffentlicht in:The New England journal of medicine 2009-09, Vol.361 (13), p.1317-1318
Hauptverfasser: Armentia, Alicia, Dueñas-Laita, Antonio, Pineda, Fernando
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Sprache:eng
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Zusammenfassung:The authors report on two women who presented with anaphylaxis a few minutes after ingesting a generic omeprazole capsule. The generic drug that each of the women took contained approved soybean oil as an excipient. To the Editor: The use of generic drugs has increased in the European Union in recent years. The main regulatory requirement for these products is that they be bioequivalent to the branded drug. However excipients such as soybean oil can be a cause of hypersensitivity reactions 1 , 2 ; the protein content of fully refined seed oils should be suspected in the case of allergic reactions. 3 We report on two women (58 and 81 years of age) who presented with anaphylaxis a few minutes after ingesting a generic omeprazole capsule. 4 , 5 In both women the systolic blood pressure fell to less . . .
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMc0904562