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Review Arranon Safety Reports submitted to FDA

Total Arranon reports: 22.
Arranon FDA safety alerts: No.
Reported deaths: 6    Reported hospitalizations: 8.
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FDA Reported Arranon Side Effects: sensory loss, neuropathy, gait disturbance, herpes zoster, monoplegia, rash erythematous, pain in extremity, cerebral haemorrhage, infection, infusion site pain, somnolence.
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Arranon Side Effects Report #5655283-7
Physician from JAPAN reported ARRANON problem on Mar 06, 2008. Male patient, 41 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased. ARRANON dosage: 250MG PER DAY. Patient recovered.

Arranon Side Effects Report #5664498-3
ARRANON problem was reported by a Physician from JAPAN on Mar 12, 2008. Male patient, 41 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood bilirubin increased. ARRANON dosage: 250MG PER DAY. Patient recovered.

Arranon Side Effects Report #5672921-3
Consumer or non-health professional from UNITED STATES reported ARRANON problem on Mar 13, 2008. Male patient, 30 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: peripheral sensory neuropathy, renal failure acute, tumour lysis syndrome. ARRANON dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Arranon Side Effects Report #5684344-1
ARRANON problem was reported by a Physician from JAPAN on Mar 25, 2008. Male patient, 41 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood bilirubin increased. ARRANON dosage: 250MG THREE TIMES PER DAY. Patient was hospitalized. Patient recovered.

Arranon Side Effects Report #5614150-5
Physician from UNITED STATES reported ARRANON problem on Feb 01, 2008. Male patient, child 12 years of age, weighting 132.3 lb, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: abasia, areflexia, aspiration, asthenia, burning sensation, dysarthria, dysphagia, eye disorder, facial paresis. ARRANON dosage: unknown. During the same period patient was treated with METHOTREXATE, SEPTRA. Patient was hospitalized and became disabled. Patient recovered.

Arranon Side Effects Report #5629386-7
ARRANON problem was reported by a Physician from JAPAN on Feb 14, 2008. Male patient, 67 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: dementia, dizziness. ARRANON dosage: 2500MG PER DAY. Patient recovered.

Arranon Side Effects Report #5537374-4
Physician from UNITED STATES reported ARRANON problem on Nov 29, 2007. Male patient, child 12 years of age, weighting 132.3 lb, was diagnosed with t-cell chronic lymphocytic leukaemia and was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: abasia, areflexia, asthenia, burning sensation, dysarthria, eye disorder, facial paresis, faecal incontinence, guillain-barre syndrome. ARRANON dosage: unknown. During the same period patient was treated with METHOTREXATE, SEPTRA. Patient was hospitalized and became disabled. Patient recovered.

Arranon Side Effects Report #5554244-6
ARRANON problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 06, 2007. Female patient, 54 years of age, weighting 164.2 lb, was diagnosed with non-hodgkin's lymphoma, gastric disorder and was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: dizziness, gait disturbance, paraesthesia, peripheral motor neuropathy. ARRANON dosage: 2550MG VARIABLE DOSE. During the same period patient was treated with GABAPENTIN, STEROIDS, PENTOSTATIN. Patient died on 10/05/2007.

Arranon Side Effects Report #5489645-8
Physician from UNITED STATES reported ARRANON problem on Oct 12, 2007. Male patient, child 12 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: abasia, areflexia, asthenia, burning sensation, dysarthria, facial paresis, hallucination, movement disorder, somnolence. ARRANON dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient recovered.

Arranon Side Effects Report #5491975-0
ARRANON problem was reported by a Physician from UNITED STATES on Oct 19, 2007. Male patient, child 12 years of age, weighting 132.3 lb, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: abasia, areflexia, asthenia, burning sensation, dysarthria, facial paresis, faecal incontinence, hallucination, movement disorder. ARRANON dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient recovered.

Arranon Side Effects Report #5499366-3
Consumer or non-health professional from UNITED STATES reported ARRANON problem on Oct 24, 2007. Female patient, 54 years of age, weighting 164.2 lb, was diagnosed with gastric disorder and was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: dizziness, paraesthesia. ARRANON dosage: unknown. During the same period patient was treated with GABAPENTIN, STEROIDS. Patient died on 10/05/2007.

Arranon Side Effects Report #5471016-1
ARRANON problem was reported by a Physician from JAPAN on Sept 21, 2007. Male patient, child 11 years of age, weighting 77.16 lb, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: herpes zoster, pain in extremity, rash erythematous. ARRANON dosage: unknown. During the same period patient was treated with BAKTAR. Patient was hospitalized. Patient recovered.

Arranon Side Effects Report #5424977-0
Physician from JAPAN reported ARRANON problem on Aug 20, 2007. Male patient, child 11 years of age, weighting 77.16 lb, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: herpes zoster. ARRANON dosage: unknown. During the same period patient was treated with BAKTAR. Patient was hospitalized. Patient recovered.

Arranon Side Effects Report #5758590-2
ARRANON problem was reported by a Pharmacist from JAPAN on May 27, 2008. Male patient, 38 years of age, was diagnosed with prophylaxis of nausea and vomiting and was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: mobility decreased, pyrexia, vertigo. ARRANON dosage: 2600MG PER DAY. During the same period patient was treated with KYTRIL, SEISHOKU, MEYLON, GLUCOSE, LANSOPRAZOLE, MAGMITT, ITRIZOLE. Patient recovered.

Arranon Side Effects Report #5793347-8
Physician from JAPAN reported ARRANON problem on June 26, 2008. Male patient, 34 years of age, weighting 172.0 lb, was diagnosed with neoplasm malignant and was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. ARRANON dosage: 1500MGM2 PER DAY. During the same period patient was treated with CYTARABINE, ETOPOSIDE, ENDOXAN. Patient was hospitalized. Patient recovered.

Arranon Side Effects Report #5736432-9
ARRANON problem was reported by a Pharmacist from JAPAN on May 08, 2008. Male patient, 38 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: mobility decreased, pyrexia, vertigo. ARRANON dosage: 2600MG PER DAY. Patient recovered.

Arranon Side Effects Report #5696090-9
Physician from JAPAN reported ARRANON problem on Apr 04, 2008. Male patient, 27 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: hepatic failure. ARRANON dosage: 2625MG PER DAY. Patient died on 03/29/2008.

Arranon Side Effects Report #5700941-9
ARRANON problem was reported by a Physician from JAPAN on Apr 09, 2008. Male patient, 34 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. ARRANON dosage: 2250MG PER DAY. Patient recovered.

Arranon Side Effects Report #5719601-3
Physician from JAPAN reported ARRANON problem on Apr 22, 2008. Male patient, 27 years of age, weighting 138.9 lb, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, cardio-respiratory arrest, disseminated intravascular coagulation, loss of consciousness. ARRANON dosage: unknown. During the same period patient was treated with KYTRIL, FUROSEMIDE, MAXIPIME, REMINARON, CALCICOL, PRIMPERAN, OXYCONTIN, NOVAMIN. Patient was hospitalized. Patient died on 03/29/2008.

Arranon Side Effects Report #5723578-4
ARRANON problem was reported by a Pharmacist from JAPAN on Apr 28, 2008. Male patient, 38 years of age, was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: pyrexia, vertigo. ARRANON dosage: unknown. Patient recovered.

Arranon Side Effects Report #5368596-3
Consumer or non-health professional from UNITED STATES reported ARRANON problem on June 12, 2007. Female patient was diagnosed with t-cell lymphoma and was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: infection. ARRANON dosage: unknown. Patient died.

Arranon Side Effects Report #5368607-5
ARRANON problem was reported by a Consumer or non-health professional from UNITED STATES on June 12, 2007. Female patient was diagnosed with t-cell lymphoma and was treated with ARRANON. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. ARRANON dosage: unknown. Patient died.


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alanine aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, , was diagnosed with t-cell chronic lymphocytic leukaemia and was diagnosed with non-hodgkin's lymphoma, gastric disorder and