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Review Ancotil Safety Reports submitted to FDA

Total Ancotil reports: 9.
Ancotil FDA safety alerts: No.
Reported deaths: 6    Reported hospitalizations: 2.
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FDA Reported Ancotil Side Effects:
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Ancotil Side Effects Report #5688166-7
Health Professional from FRANCE reported ANCOTIL problem on Mar 14, 2008. Male patient, 49 years of age, was diagnosed with cryptococcosis and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: arachnoiditis, aspartate aminotransferase increased, blood pressure increased, gamma-glutamyltransferase increased, neurological symptom, oxygen saturation decreased, renal failure acute, sensory disturbance, vasculitis cerebral. ANCOTIL dosage: 2 MG;TID;IV. During the same period patient was treated with AMBISOME, AMPHOTERICIN B. Patient was hospitalized. Patient recovered.

Ancotil Side Effects Report #5701090-6
ANCOTIL problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Mar 25, 2008. Female patient, weighting 6.39 lb, was diagnosed with candidiasis and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: cardiotoxicity, myocardial infarction, neonatal disorder. ANCOTIL dosage: 75 MG; QD; IV. During the same period patient was treated with AMBISOME, CASPOFUNGIN, VANCOMYCIN, INOTROPES, AMIKARIN. Patient recovered.

Ancotil Side Effects Report #5706592-4
Physician from UNITED KINGDOM reported ANCOTIL problem on Feb 07, 2002. Female patient, child 9 years of age, weighting 55.12 lb, was diagnosed with fungal infection, bronchopulmonary aspergillosis and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: bronchopulmonary aspergillosis, chest pain, oedema peripheral, respiratory disorder, respiratory failure. ANCOTIL dosage: unknown. During the same period patient was treated with AMBISOME. Patient died on 12/07/2000.

Ancotil Side Effects Report #5706593-6
ANCOTIL problem was reported by a Consumer or non-health professional from GERMANY on Oct 02, 2000. Male patient, 52 years of age, was diagnosed with candidiasis and was treated with ANCOTIL. ANCOTIL dosage: unknown. During the same period patient was treated with AMPHOTERICIN B, AMPHOTERICIN B, AMPHOTERICIN B, FLUCONAZOLE. Patient died on 02/27/2000.

Ancotil Side Effects Report #5706594-8
Physician from UNITED KINGDOM reported ANCOTIL problem on Oct 24, 2001. Male patient, 52 years of age, weighting 169.8 lb, was diagnosed with aspergillosis and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, collapse of lung, multi-organ failure, oesophageal ulcer, sinus bradycardia. ANCOTIL dosage: unknown. During the same period patient was treated with AMPHOTERICIN B, AMPHOTERICIN B, AMPHOTERICIN B, CORTICOSTEROID NOS, FLUCONAZOLE. Patient died on 01/07/2001.

Ancotil Side Effects Report #5706619-X
ANCOTIL problem was reported by a Physician from GERMANY on Aug 15, 2000. Male patient, 44 years of age, was diagnosed with bronchopulmonary aspergillosis, fungal infection and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, disease progression, pancytopenia, pulmonary haemorrhage, renal failure. ANCOTIL dosage: unknown. During the same period patient was treated with AMPHOTERICIN B. Patient died on 07/27/2000.

Ancotil Side Effects Report #5706620-6
Consumer or non-health professional from GERMANY reported ANCOTIL problem on June 30, 2000. Female patient, 76 years of age, was diagnosed with fungal infection and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: arrhythmia. ANCOTIL dosage: unknown. Patient died on 05/14/2000.

Ancotil Side Effects Report #5706622-X
ANCOTIL problem was reported by a Consumer or non-health professional from UNITED KINGDOM on May 30, 2002. Male patient, 50 years of age, was diagnosed with candidiasis and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, fluid overload, fungal infection, hepatic function abnormal, neutropenia, sepsis, thrombocytopenia. ANCOTIL dosage: unknown. During the same period patient was treated with AMPHOTERICIN B. Patient died on 04/29/2002.

Ancotil Side Effects Report #5708383-7
Health Professional from FRANCE reported ANCOTIL problem on Mar 04, 2008. Male patient, 43 years of age, was diagnosed with oesophageal candidiasis and was treated with ANCOTIL. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, pancreatitis acute. ANCOTIL dosage: 2.5 MG;IV. During the same period patient was treated with ACYCLOVIR, AMBISOME, CASPOFUNGIN ACETATE, TENOFOVIR DISOPROXIL FUMARATE, BACTRIM DS. Patient was hospitalized. Patient recovered.


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arachnoiditis, aspartate aminotransferase increased, blood pressure increased, gamma-glutamyltransferase increased, neurological symptom, oxygen saturation decreased, renal failure acute, sensory disturbance, vasculitis cerebral, , was diagnosed with cryptococcosis and was diagnosed with candidiasis and was diagnosed with fungal infection, bronchopulmonary aspergillosis and