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Valcyte Safety Reports submitted to FDA

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Total Valcyte reports: 24.
Valcyte FDA safety alerts: 2003 .
Reported deaths: 2    Reported hospitalizations: 12.
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FDA Reported Valcyte Side Effects: c-reactive protein increased, white blood cell count decreased, pyrexia, neutropenia, platelet count decreased, red blood cell count decreased, pancytopenia, neutrophil count decreased, cough, cardiomegaly, bronchitis.
Valcyte Usage.
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Valcyte Side Effects Report #5195714-2
Physician from GERMANY reported VALCYTE problem on Dec 22, 2006. Male patient, 23 years of age, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: pneumonia. VALCYTE dosage: unknown. Patient recovered.

Valcyte Side Effects Report #5199963-9
VALCYTE problem was reported by a Physician from GERMANY on Dec 22, 2006. Male patient, 23 years of age, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: pneumonia. VALCYTE dosage: unknown. Patient recovered.

Valcyte Side Effects Report #5209177-1
Physician from GERMANY reported VALCYTE problem on Jan 09, 2007. Male patient, 64 years of age, weighting 176.4 lb, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, leukopenia. VALCYTE dosage: unknown. Patient recovered.

Valcyte Side Effects Report #5210559-2
VALCYTE problem was reported by a Physician from GERMANY on Jan 09, 2007. Female patient, 52 years of age, weighting 141.1 lb, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, c-reactive protein increased, creatinine renal clearance decreased, leukopenia, platelet count decreased. VALCYTE dosage: unknown. During the same period patient was treated with FOSCAVIR. Patient recovered.

Valcyte Side Effects Report #5210562-2
Physician from GERMANY reported VALCYTE problem on Jan 09, 2007. Male patient, 53 years of age, weighting 136.7 lb, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased. VALCYTE dosage: unknown. During the same period patient was treated with CELLCEPT. Patient recovered.

Valcyte Side Effects Report #5220717-9
VALCYTE problem was reported by a Physician from GERMANY on Jan 18, 2007. Male patient, 53 years of age, weighting 136.7 lb, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, multi-organ failure. VALCYTE dosage: unknown. During the same period patient was treated with CELLCEPT. Patient died on 04/01/2005.

Valcyte Side Effects Report #5220740-4
Physician from GERMANY reported VALCYTE problem on Jan 18, 2007. Male patient, 53 years of age, weighting 136.7 lb, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, multi-organ failure. VALCYTE dosage: unknown. During the same period patient was treated with CELLCEPT. Patient died on 04/01/2005.

Valcyte Side Effects Report #5272790-X
VALCYTE problem was reported by a Physician from GERMANY on Mar 13, 2007. Male patient was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: neutropenia, pneumocystis jiroveci pneumonia. VALCYTE dosage: unknown. Patient recovered.

Valcyte Side Effects Report #5288667-X
Physician from GERMANY reported VALCYTE problem on Mar 27, 2007. Male patient, 48 years of age, was diagnosed with immunosuppression and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: neutropenia, pneumocystis jiroveci pneumonia. VALCYTE dosage: unknown. During the same period patient was treated with CELLCEPT, PROGRAF, DECORTIN H. Patient recovered.

Valcyte Side Effects Report #5296365-1
VALCYTE problem was reported by a Physician from GERMANY on Apr 02, 2007. Male patient, child 5 years of age, weighting 37.92 lb, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, convulsion, electrolyte imbalance, metabolic acidosis. VALCYTE dosage: unknown. During the same period patient was treated with GANCICLOVIR, RAPAMUNE, DECORTIN, TRILEPTAL, MAGNESIUM VERLA DRAGEES, ENALAPRIL MALEATE, LORZAAR. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5317469-0
Health Professional from UNITED STATES reported VALCYTE problem on Apr 24, 2007. Male patient, 40 years of age, was diagnosed with renal transplant and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: bronchitis, cardiomegaly, cough, neutrophil count decreased, pancytopenia, platelet count decreased, pyrexia, red blood cell count decreased, white blood cell count decreased. VALCYTE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, BACTRIM, LEVOFLOXACIN, MYCOPHENOLATE MOFETIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5322572-5
VALCYTE problem was reported by a Physician from GERMANY on Mar 27, 2007. Male patient, 48 years of age, was diagnosed with immunosuppression and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: neutropenia, pneumocystis jiroveci pneumonia. VALCYTE dosage: unknown. During the same period patient was treated with CELLCEPT, PROGRAF, DECORTIN H. Patient recovered.

Valcyte Side Effects Report #5326177-1
Physician from GERMANY reported VALCYTE problem on May 07, 2007. Male patient, child 5 years of age, weighting 37.92 lb, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, convulsion, electrolyte imbalance, erythema, grand mal convulsion, heart rate increased, hypertrichosis, hypokalaemia. VALCYTE dosage: unknown. During the same period patient was treated with GANCICLOVIR, RAPAMUNE, DECORTIN, TRILEPTAL, MAGNESIUM VERLA DRAGEES, ENALAPRIL, LORZAAR. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5355084-3
VALCYTE problem was reported by a Pharmacist from UNITED STATES on Aug 29, 2006. Female patient was diagnosed with cytomegalovirus colitis and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus colitis, disease progression. VALCYTE dosage: unknown. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5355085-5
Consumer or non-health professional from UNITED STATES reported VALCYTE problem on Feb 22, 2007. Male patient, 65 years of age, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus infection. VALCYTE dosage: unknown. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5055147-6
VALCYTE problem was reported by a Consumer or non-health professional from SWITZERLAND on July 07, 2006. Male patient, 24 years of age, weighting 125.7 lb, was diagnosed with cytomegalovirus infection and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, dizziness, dysphagia, nausea, nystagmus, vomiting. VALCYTE dosage: unknown. During the same period patient was treated with BACTRIM, FRAXIFORTE, FRAXIPARINE. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5076682-0
Physician from UNITED STATES reported VALCYTE problem on July 30, 2006. Male patient, 59 years of age, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: anaemia, leukaemia, myelocyte count increased. VALCYTE dosage: unknown. During the same period patient was treated with PROGRAF, PREDNISONE, CELLCEPT, CIPRO. Patient recovered.

Valcyte Side Effects Report #5094881-9
VALCYTE problem was reported by a Health Professional from UNITED STATES on Mar 14, 2006. Male patient, 40 years of age, was diagnosed with renal transplant and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: bronchitis, cardiomegaly, cough, neutrophil count decreased, pancytopenia, platelet count decreased, pyrexia, red blood cell count decreased, white blood cell count decreased. VALCYTE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, BACTRIM, LEVOFLOXACIN, MYCOPHENOLATE MOFETIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5113880-1
Consumer or non-health professional from UNITED STATES reported VALCYTE problem on Sept 14, 2006. Female patient, 55 years of age, weighting 149.9 lb, was diagnosed with sarcoidosis, pain, osteopenia, asthma, menopause and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: cytomegalovirus colitis. VALCYTE dosage: unknown. During the same period patient was treated with CELLCEPT, PREDNISONE, MS CONTIN, POTASSIUM, CALTRATE, DUONEB, ESTRADIOL, FOSAMAX. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5124644-7
VALCYTE problem was reported by a Pharmacist from UNITED STATES on Oct 06, 2006. Female patient was diagnosed with antiviral prophylaxis, immunosuppression and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: neutropenia, white blood cell count decreased. VALCYTE dosage: 450MG EVERY OTHER DAY PO. During the same period patient was treated with MYCOPHENOLATE, TACROLIMUS, PREDNISONE, CIPROFLOXACIN, CLOTRIMAZOLE, NEUPOGEN, VICODIN, VANCOMYCIN. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5127642-2
Health Professional from UNITED STATES reported VALCYTE problem on Mar 14, 2006. Male patient, 40 years of age, was diagnosed with renal transplant and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: bronchitis, cardiomegaly, cough, neutrophil count decreased, pancytopenia, platelet count decreased, pyrexia, red blood cell count decreased, white blood cell count decreased. VALCYTE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, BACTRIM, LEVOFLOXACIN, MYCOPHENOLATE MOFETIL, PREDNISONE. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5134795-9
VALCYTE problem was reported by a Physician from GERMANY on Oct 13, 2006. Male patient, child 5 years of age, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, pyrexia. VALCYTE dosage: unknown. Patient recovered.

Valcyte Side Effects Report #5380807-7
Consumer or non-health professional from UNITED STATES reported VALCYTE problem on June 28, 2007. Female patient, 67 years of age, was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: dehydration, vomiting. VALCYTE dosage: unknown. Patient was hospitalized. Patient recovered.

Valcyte Side Effects Report #5401529-X
VALCYTE problem was reported by a Physician from SWITZERLAND on July 20, 2007. Male patient, 62 years of age, was diagnosed with hiv infection, prostatic disorder, pain and was treated with VALCYTE. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative, photosensitivity reaction, rash erythematous. VALCYTE dosage: unknown. During the same period patient was treated with STOCRIN, PANTOPRAZOLE, LAMIVUDINE, VIREAD, KEPPRA, PRADIF, DURAGESIC. Patient was hospitalized. Patient recovered.

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