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Review Palifermin Safety Reports submitted to FDA

Total Palifermin reports: 9.
Palifermin FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 19.
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FDA Reported Palifermin Side Effects: hypersensitivity, fluid retention, burning sensation, pruritus, dermatitis exfoliative, stomatitis, capillary leak syndrome, febrile neutropenia, mucosal inflammation, bacteraemia, refusal of treatment by patient.
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Palifermin Side Effects Report #5624476-7
Physician from AUSTRALIA reported PALIFERMIN problem on Jan 30, 2008. Female patient, weighting 167.8 lb, was diagnosed with stomatitis and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. PALIFERMIN dosage: unknown. During the same period patient was treated with ALLOPURINOL, BACTRIM DS. Patient recovered.

Palifermin Side Effects Report #5608514-3
PALIFERMIN problem was reported by a Physician from AUSTRALIA on Jan 16, 2008. Female patient, weighting 167.8 lb, was diagnosed with stomatitis and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. PALIFERMIN dosage: unknown. During the same period patient was treated with ALLOPURINOL, BACTRIM DS. Patient recovered.

Palifermin Side Effects Report #5537332-X
Physician from AUSTRALIA reported PALIFERMIN problem on Nov 26, 2007. Female patient, weighting 167.8 lb, was diagnosed with stomatitis and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. PALIFERMIN dosage: unknown. During the same period patient was treated with ALLOPURINOL, BACTRIM DS. Patient recovered.

Palifermin Side Effects Report #5412363-9
PALIFERMIN problem was reported by a Physician from UNITED STATES on Aug 07, 2007. Male patient, weighting 270.7 lb, was diagnosed with hiv infection and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: laryngeal cancer. PALIFERMIN dosage: unknown. During the same period patient was treated with SUSTIVA, TRUVADA, DAPSONE, ACTOS, NEURONTIN, TENORMIN, CRESTOR, ZAROXOLYN. Patient was hospitalized. Patient recovered.

Palifermin Side Effects Report #5423519-3
Physician from UNITED STATES reported PALIFERMIN problem on Aug 13, 2007. Male patient, 44 years of age, weighting 189.2 lb, was diagnosed with hiv infection and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: basal cell carcinoma. PALIFERMIN dosage: unknown. During the same period patient was treated with RITALIN, PROPECIA, MINOCIN, TEMAZEPAM, LORAZEPAM, RITONAVIR, TRUVADA, TRIZIVIR. Patient was hospitalized. Patient recovered.

Palifermin Side Effects Report #5700826-8
PALIFERMIN problem was reported by a Health Professional from BELGIUM on Mar 28, 2008. Male patient, weighting 122.4 lb, was diagnosed with mucosal inflammation and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: anorexia, fatigue. PALIFERMIN dosage: unknown. Patient was hospitalized. Patient recovered.

Palifermin Side Effects Report #5322149-1
Consumer or non-health professional from POLAND reported PALIFERMIN problem on May 02, 2007. Male patient, 19 years of age, was diagnosed with mucosal inflammation and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: dermatitis acneiform, febrile neutropenia, gingivitis, glossitis, infection, viral pharyngitis. PALIFERMIN dosage: unknown. During the same period patient was treated with CORTICOSTEROIDS, BUSULFAN, CYCLOPHOSPHAMIDE, ATGAM, ITRACONAZOLE, ACYCLOVIR, TAZOCIN, MAXIPIME. Patient recovered.

Palifermin Side Effects Report #5297771-1
PALIFERMIN problem was reported by a Pharmacist from UNITED STATES on Apr 12, 2007. Female patient, 51 years of age, weighting 134.0 lb, was diagnosed with mucosal inflammation, prophylaxis and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: angioedema, dry throat, obstructive airways disorder, paraesthesia oral, rash, wheezing. PALIFERMIN dosage: 3.5 MG DAILY IV. Patient recovered.

Palifermin Side Effects Report #5268278-2
Consumer or non-health professional from NETHERLANDS reported PALIFERMIN problem on Mar 07, 2007. Female patient, weighting 183.0 lb, was diagnosed with mucosal inflammation and was treated with PALIFERMIN. After drug was administered, patient experienced the following problems/side effects: blister, epidermolysis, exfoliative rash, oedema, palmar-plantar erythrodysaesthesia syndrome, pruritus. PALIFERMIN dosage: unknown. During the same period patient was treated with CARMUSTINE, ETOPOSIDE, METHOTREXATE, MELPHALAN. Patient was hospitalized. Patient recovered.


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