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Review Foscavir Safety Reports submitted to FDA

Total Foscavir reports: 15.
Foscavir FDA safety alerts: No.
   Reported hospitalizations: 5.
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FDA Reported Foscavir Side Effects: pulmonary alveolar haemorrhage, depressed level of consciousness, tongue paralysis, renal impairment, pyrexia, hypokalaemia, haemoglobin decreased, appendicitis, bradycardia, platelet disorder, blood amylase increased.
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Foscavir Side Effects Report #5615448-7
Physician from JAPAN reported FOSCAVIR problem on Feb 04, 2008. Male patient, weighting 127.9 lb, was diagnosed with infection prophylaxis, encephalitis cytomegalovirus, hiv infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, bone marrow failure, c-reactive protein increased, cerebral toxoplasmosis, disseminated intravascular coagulation, eating disorder, encephalitis, hypoalbuminaemia, loss of consciousness. FOSCAVIR dosage: unknown. Patient was hospitalized. Patient recovered.

Foscavir Side Effects Report #5579081-8
FOSCAVIR problem was reported by a Health Professional from ITALY on Dec 27, 2007. Male patient, child 12 years of age, weighting 72.75 lb, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, cerebral haemorrhage. FOSCAVIR dosage: unknown. During the same period patient was treated with ACYCLOVIR, DESAMETASONE, DIFLUCAN, CIPROXIN, MEPRAL. Patient recovered.

Foscavir Side Effects Report #5599822-3
Physician from JAPAN reported FOSCAVIR problem on Nov 13, 2007. Male patient, weighting 127.9 lb, was diagnosed with hiv infection, encephalitis cytomegalovirus and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, c-reactive protein increased, pancytopenia. FOSCAVIR dosage: unknown. During the same period patient was treated with VALGANCICLOVIR, EPZICOM. Patient recovered.

Foscavir Side Effects Report #5600411-2
FOSCAVIR problem was reported by a Physician from JAPAN on Nov 28, 2007. Male patient, weighting 127.9 lb, was diagnosed with infection prophylaxis, encephalitis cytomegalovirus, hiv infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, bone marrow failure, c-reactive protein increased, cerebral toxoplasmosis, disseminated intravascular coagulation, eating disorder, encephalitis, hypoalbuminaemia, loss of consciousness. FOSCAVIR dosage: unknown. Patient was hospitalized. Patient recovered.

Foscavir Side Effects Report #5604687-7
Physician from JAPAN reported FOSCAVIR problem on Jan 21, 2008. Male patient, weighting 127.9 lb, was diagnosed with infection prophylaxis, encephalitis cytomegalovirus, hiv infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, bone marrow failure, c-reactive protein increased, cerebral toxoplasmosis, disseminated intravascular coagulation, eating disorder, encephalitis, hypoalbuminaemia, loss of consciousness. FOSCAVIR dosage: unknown. Patient was hospitalized. Patient recovered.

Foscavir Side Effects Report #5542485-3
FOSCAVIR problem was reported by a Health Professional from ITALY on Dec 06, 2007. Male patient, child 12 years of age, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. FOSCAVIR dosage: unknown. During the same period patient was treated with ACYCLOVIR, DESAMETASONE, DIFLUCAN, CIPROXIN, MEPRAL, PROZAC, NUREFLEX, ROCALTROL. Patient recovered.

Foscavir Side Effects Report #5546950-4
Health Professional from ITALY reported FOSCAVIR problem on Dec 06, 2007. Male patient, child 12 years of age, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, cerebral haemorrhage. FOSCAVIR dosage: unknown. During the same period patient was treated with ACYCLOVIR, DESAMETASONE, DIFLUCAN, CIPROXIN, MEPRAL, PROZAC, NUREFLEX, ROCALTROL. Patient recovered.

Foscavir Side Effects Report #5516893-0
FOSCAVIR problem was reported by a Pharmacist from UNITED KINGDOM on Nov 05, 2007. Female patient, 41 years of age, weighting 167.6 lb, was diagnosed with cytomegalovirus infection, immunosuppression, hypercholesterolaemia, depression and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: genital discomfort, genital ulceration. FOSCAVIR dosage: 84 MG/KG/DAY GIVEN TWICE DAILY. During the same period patient was treated with TACROLIMUS, PREDNISOLONE, ATORVASTATIN CALCIUM, FLUOXETINE. Patient recovered.

Foscavir Side Effects Report #5521154-X
Health Professional from ITALY reported FOSCAVIR problem on Nov 14, 2007. Male patient, child 12 years of age, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, convulsion, headache, loss of consciousness, paraesthesia oral, vision blurred. FOSCAVIR dosage: unknown. Patient recovered.

Foscavir Side Effects Report #5522316-8
FOSCAVIR problem was reported by a Pharmacist from UNITED STATES on Nov 13, 2007. Male patient, 16 years of age, weighting 256.0 lb, was diagnosed with cytomegalovirus test positive and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: amnesia, confusional state, fatigue, ill-defined disorder, mental status changes. FOSCAVIR dosage: unknown. During the same period patient was treated with AMLODIPINE, CEFEPIME, LISINOPRIL, MAGNESIUM OXIDE. Patient was hospitalized. Patient recovered.

Foscavir Side Effects Report #5523623-5
Health Professional from ITALY reported FOSCAVIR problem on Nov 19, 2007. Male patient, child 12 years of age, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, convulsion, encephalopathy, headache, loss of consciousness, paraesthesia oral, vision blurred. FOSCAVIR dosage: unknown. During the same period patient was treated with ACYCLOVIR, DESAMETASONE, DIFLUCAN, CIPROXIN, MEPRAL, PROZAC, NUREFLEX, ROCALTROL. Patient recovered.

Foscavir Side Effects Report #5525895-X
FOSCAVIR problem was reported by a Health Professional from ITALY on Nov 19, 2007. Male patient, child 12 years of age, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, convulsion, encephalopathy, headache, loss of consciousness, paraesthesia oral, vision blurred. FOSCAVIR dosage: unknown. During the same period patient was treated with ACYCLOVIR, DESAMETASONE, DIFLUCAN, CIPROXIN, MEPRAL, PROZAC, NUREFLEX, ROCALTROL. Patient recovered.

Foscavir Side Effects Report #5527783-1
Physician from JAPAN reported FOSCAVIR problem on Nov 13, 2007. Male patient, weighting 127.9 lb, was diagnosed with hiv infection, encephalitis cytomegalovirus and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, c-reactive protein increased, pancytopenia. FOSCAVIR dosage: unknown. During the same period patient was treated with VALGANCICLOVIR, EPZICOM. Patient recovered.

Foscavir Side Effects Report #5384034-9
FOSCAVIR problem was reported by a Pharmacist from UNITED KINGDOM on June 29, 2007. Female patient, child 11 years of age, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased. FOSCAVIR dosage: unknown. Patient recovered.

Foscavir Side Effects Report #5384034-9
Pharmacist from UNITED KINGDOM reported FOSCAVIR problem on June 29, 2007. Female patient, child 11 years of age, was diagnosed with cytomegalovirus infection and was treated with FOSCAVIR. After drug was administered, patient experienced the following problems/side effects: haemoglobin decreased. FOSCAVIR dosage: unknown. Patient recovered.


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acute respiratory failure, bone marrow failure, c-reactive protein increased, cerebral toxoplasmosis, disseminated intravascular coagulation, eating disorder, encephalitis, hypoalbuminaemia, loss of consciousness, , was diagnosed with infection prophylaxis, encephalitis cytomegalovirus, hiv infection and was diagnosed with cytomegalovirus infection and