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Write-up: Hematoma muscle; Anemia; The patient received Apixaban at 2.5 mg/24h for atrial fibrillation; This is a spontaneous report from a contactable physician via regulatory authority (regulatory authority number: ES-AEMPS-798845), based on information received by Pfizer from a company (manufacturer control number: ES-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-031295) through regulatory authority, license party for apixaban (ELIQUIS). This case was received via HA (Reference number: ES-AEMPS-798845) on 29Mar2021 and was forwarded to regulatory authority on 29Mar2021. This spontaneous case was reported by a physician and describes the occurrence of HAEMATOMA MUSCLE (Hematoma muscle) and ANAEMIA (Anemia) in 86-year-old female patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunization. Product or product use issues identified: OFF LABEL USE (The patient received Apixaban at 2.5 mg/24h for atrial fibrillation) on 01Jan2020. The patient''s past medical history included Cardiovascular disease, unspecified and Chronic kidney disease. On 01Jan2020, the patient started Eliquis (Oral), 2.5 milligram once a day. On 05Jan2021, the patient started Covid-19 Vaccine (Intramuscular). On 05Jan2021, the patient experienced HAEMATOMA MUSCLE (seriousness criterion hospitalization) and ANAEMIA (seriousness criterion hospitalization). Eliquis (Oral) was withdrawn on 05Jan2021. At the time of the report, HAEMATOMA MUSCLE and ANAEMIA was resolving. Therapy with COVID-19 vaccine and Apixaban was withdrawn on 05Jan2021. Causality was not provided for COVID-19 vaccine. The patient died due to cardiac failure and chronic kidney disease on 12Jan2021. For Eliquis (Oral), the reporter did not provide any causality assessments. Follow-up not performed, as case was downloaded from regulatory authority. Regulatory authority medical evaluation comment: This patient had muscle hematoma and anemia after therapy with apixaban. Based on the anticoagulant action of the suspect drug, its contributory role in these reported events are considered as possible. Causality Assessment: The events "Hematoma muscle, Anemia" were considered related to ELIQUIS by Company). The event "Off label dosing frequency" was considered unrelated to ELIQUIS by Company.; Sender''s Comments: Regulatory authority medical evaluation comment: This patient had muscle hematoma and anemia after therapy with apixaban. Based on the anticoagulant action of the suspect drug, its contributory role in these reported events are considered as possible.; Reported Cause(s) of Death: cardiac failure; chronic kidney disease
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