Complement C1 inhibitor protein
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Complement C1 inhibitor protein
Thrombotic events and other toxicities: 17 case reports In a retrospective study of the FDA AERS database, 15 females and two males aged 10–68 years were identified who developed various toxicities, including thrombotic events, during treatment with complement C1 inhibitor protein [Cinryze]. All 17 patients were receiving complement C1 inhibitor protein for prophylaxis of hereditary angioedema [routes, dosages and durations of treatment to reactions onset not stated]. The reported events are listed in Table 1. Twelve patients were hospitalised and five had another unspecified serious outcome. The event was life-threatening in one case, and resulted in death in another case [remaining outcomes not stated].
List of event/s reported Event/s reported Deep vein thrombosis Transient ischaemic attack Myocardial infarction Pulmonary embolism Embolic stroke, intracardiac thrombus Hypotension, lactic acidosis, haemodynamic instability, cardiac disorder, abdominal pain, acute renal failure Ischaemic colitis Back pain, hereditary angioedema, musculoskeletal pain, pain in extremity Cardiac flutter Intestinal ischaemia, ileus, duodenitis, colitis Transient blindness, migraine Supraventricular tachycardia
# cases 2 2 1 2 1 1
1 1 1 1 1 1
Author comment: "The combination case reports of [complement C1 inhibitor protein] and thrombotic events extracted from the database corresponded to 10 confirmed cases of a [complement C1 inhibitor protein]–associated thrombotic event. . . In addition to the 10 confirmed combination cases, seven combination cases characterized as possible were identified." Gandhi PK, et al. Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: Investigation from the United States food and drug administration adverse event reporting system database. Pharmacotherapy 32: 902-909, No. 10, Oct 2012. Available from: URL: http://dx.doi.org/10.1002/ 803081071 j.1875-9114.2012.01126 - USA
0114-9954/10/1432-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 15 Dec 2012 No. 1432
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