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Review Valixa Safety Reports submitted to FDA

Total Valixa reports: 11.
Valixa FDA safety alerts: No.
   Reported hospitalizations: 4.
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FDA Reported Valixa Side Effects: immune reconstitution syndrome, kaposi's sarcoma, bone marrow failure, visual field defect, atypical mycobacterial infection, white blood cell count decreased, hypertriglyceridaemia, rash, cytomegalovirus chorioretinitis, inappropriate antidiuretic hormone secretion, hyponatraemia.
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Valixa Side Effects Report #5507896-0
Physician from JAPAN reported VALIXA problem on Oct 26, 2007. Male patient, 41 years of age, was diagnosed with cytomegalovirus chorioretinitis, hiv infection and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, cytomegalovirus chorioretinitis, herpes zoster, immune reconstitution syndrome, rash. VALIXA dosage: unknown. During the same period patient was treated with RETROVIR, EPIVIR, LEXIVA, ZERIT, BAKTAR. Patient was hospitalized. Patient recovered.

Valixa Side Effects Report #5492177-4
VALIXA problem was reported by a Physician from JAPAN on Oct 11, 2007. Male patient, 41 years of age, was diagnosed with cytomegalovirus oesophagitis, hiv infection and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: atypical mycobacterial infection, hepatic function abnormal, immune reconstitution syndrome, kaposi's sarcoma, lymphoma, progressive multifocal leukoencephalopathy, visual field defect. VALIXA dosage: unknown. During the same period patient was treated with REYATAZ, CLARITHROMYCIN, ESANBUTOL, ZITHROMAX, RIFABUTIN, BAKTAR. Patient recovered.

Valixa Side Effects Report #5464349-6
Physician from JAPAN reported VALIXA problem on Sept 11, 2007. Male patient, 49 years of age, was diagnosed with encephalitis cytomegalovirus, hiv infection and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: acute respiratory failure, cerebral toxoplasmosis, disseminated intravascular coagulation, eating disorder, encephalitis, loss of consciousness, pancytopenia, pneumothorax, respiratory arrest. VALIXA dosage: unknown. During the same period patient was treated with COMBIVIR, KALETRA, FOSCAVIR, EPZICOM, REYATAZ. Patient was hospitalized. Patient recovered.

Valixa Side Effects Report #5464409-X
VALIXA problem was reported by a Physician from JAPAN on Sept 10, 2007. Male patient, 63 years of age, was diagnosed with cytomegalovirus antigen positive and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: hyponatraemia, inappropriate antidiuretic hormone secretion. VALIXA dosage: unknown. During the same period patient was treated with BAKTAR, PREDONINE, ITRACONAZOLE, CLARITHROMYCIN, FLUCONAZOLE. Patient recovered.

Valixa Side Effects Report #5465686-1
Physician from JAPAN reported VALIXA problem on Sept 13, 2007. Male patient, 41 years of age, was diagnosed with cytomegalovirus oesophagitis, hiv infection and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: atypical mycobacterial infection, hepatic function abnormal, kaposi's sarcoma, visual field defect. VALIXA dosage: unknown. During the same period patient was treated with REYATAZ, CLARITHROMYCIN, ESANBUTOL, ZITHROMAX, RIFABUTIN, BAKTAR. Patient recovered.

Valixa Side Effects Report #5467183-6
VALIXA problem was reported by a Physician from JAPAN on Sept 13, 2007. Male patient, 41 years of age, was diagnosed with cytomegalovirus chorioretinitis, hiv infection and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, cytomegalovirus chorioretinitis, herpes zoster, immune reconstitution syndrome, rash. VALIXA dosage: unknown. During the same period patient was treated with RETROVIR, EPIVIR, LEXIVA, ZERIT, BAKTAR. Patient was hospitalized. Patient recovered.

Valixa Side Effects Report #5411288-2
Physician from JAPAN reported VALIXA problem on Aug 02, 2007. Male patient, 63 years of age, was diagnosed with cytomegalovirus antigen positive and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: hyponatraemia, inappropriate antidiuretic hormone secretion. VALIXA dosage: unknown. During the same period patient was treated with BAKTAR. Patient recovered.

Valixa Side Effects Report #5416781-4
VALIXA problem was reported by a Physician from JAPAN on Aug 07, 2007. Male patient, 41 years of age, was diagnosed with cytomegalovirus chorioretinitis, hiv infection and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, cytomegalovirus chorioretinitis, immune reconstitution syndrome, rash. VALIXA dosage: unknown. During the same period patient was treated with RETROVIR, EPIVIR, LEXIVA, ZERIT, BAKTAR. Patient was hospitalized. Patient recovered.

Valixa Side Effects Report #5416795-4
Physician from JAPAN reported VALIXA problem on Aug 07, 2007. Male patient, 42 years of age, was diagnosed with cytomegalovirus oesophagitis and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: kaposi's sarcoma, visual field defect. VALIXA dosage: unknown. During the same period patient was treated with BAKTAR, DIFLUCAN, FUNGIZONE, NORVIR, REYATAZ, EPZICOM, CLARITHROMYCIN, ESANBUTOL. Patient recovered.

Valixa Side Effects Report #5394138-2
VALIXA problem was reported by a Physician from JAPAN on July 11, 2007. Male patient, 42 years of age, was diagnosed with cytomegalovirus oesophagitis and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: immune reconstitution syndrome, impaired driving ability, kaposi's sarcoma, progressive multifocal leukoencephalopathy, visual field defect. VALIXA dosage: unknown. During the same period patient was treated with BAKTAR, DIFLUCAN, FUNGIZONE, NORVIR, REYATAZ, EPZICOM, CLARITHROMYCIN, ESANBUTOL. Patient recovered.

Valixa Side Effects Report #5394138-2
Physician from JAPAN reported VALIXA problem on July 11, 2007. Male patient, 42 years of age, was diagnosed with cytomegalovirus oesophagitis and was treated with VALIXA. After drug was administered, patient experienced the following problems/side effects: immune reconstitution syndrome, impaired driving ability, kaposi's sarcoma, progressive multifocal leukoencephalopathy, visual field defect. VALIXA dosage: unknown. During the same period patient was treated with BAKTAR, DIFLUCAN, FUNGIZONE, NORVIR, REYATAZ, EPZICOM, CLARITHROMYCIN, ESANBUTOL. Patient recovered.


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