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Review Hydroxycarbamide Safety Reports submitted to FDA

Total Hydroxycarbamide reports: 8.
Hydroxycarbamide FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 1.
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FDA Reported Hydroxycarbamide Side Effects: vision blurred, pancytopenia, nail pigmentation, muscular weakness, dizziness, dysphagia, tumour lysis syndrome, bone marrow failure.
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Hydroxycarbamide Side Effects Report #5566262-2
Health Professional from SPAIN reported HYDROXYCARBAMIDE problem on Dec 17, 2007. Female patient, 56 years of age, was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: photosensitivity reaction. HYDROXYCARBAMIDE dosage: unknown. During the same period patient was treated with ISONIAZID, ETHAMBUTOL HYDROCHLORIDE, LOSARTAN POTASSIUM, SPIRONOLACTONE. Patient recovered.

Hydroxycarbamide Side Effects Report #5571435-9
HYDROXYCARBAMIDE problem was reported by a Health Professional from UNITED STATES on Dec 17, 2007. Male patient, 58 years of age, was diagnosed with glioblastoma multiforme and was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: anaemia, leukopenia, malignant neoplasm progression, thrombocytopenia. HYDROXYCARBAMIDE dosage: DOSE REDUCED DECREASED TO 500 MG ONCE DAILY.. During the same period patient was treated with SULFAMETHOXAZOLE AND TRIMETHOPRIM, GLEEVEC, LEVETIRACETAM, PANTOPRAZOLE, LEVOTHYROXINE, DEXAMETHASONE. Patient died.

Hydroxycarbamide Side Effects Report #5574592-3
Health Professional from SPAIN reported HYDROXYCARBAMIDE problem on Dec 26, 2007. Female patient, 56 years of age, was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: photosensitivity reaction. HYDROXYCARBAMIDE dosage: unknown. During the same period patient was treated with ISONIAZID, ETHAMBUTOL HYDROCHLORIDE, LOSARTAN POTASSIUM, SPIRONOLACTONE. Patient recovered.

Hydroxycarbamide Side Effects Report #5503781-9
HYDROXYCARBAMIDE problem was reported by a Health Professional from UNITED KINGDOM on June 08, 2007. Female patient, 52 years of age, weighting 154.3 lb, was diagnosed with polycythaemia vera, prophylaxis and was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: back pain, neck pain, pyrexia, rash maculo-papular. HYDROXYCARBAMIDE dosage: unknown. During the same period patient was treated with ALLOPURINOL, ASPIRIN, SUMATRIPTAN SUCCINATE, LEVOTHYROXINE. Patient recovered.

Hydroxycarbamide Side Effects Report #5515854-5
Health Professional from UNITED KINGDOM reported HYDROXYCARBAMIDE problem on Nov 09, 2007. Male patient, 66 years of age, weighting 167.6 lb, was diagnosed with psoriasis, prophylaxis, stomach discomfort, pain, myalgia and was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, chills, diarrhoea, hyperhidrosis. HYDROXYCARBAMIDE dosage: unknown. During the same period patient was treated with ALENDRONIC ACID, LANSOPRAZOLE, PARACETAMOL, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Hydroxycarbamide Side Effects Report #5520145-2
HYDROXYCARBAMIDE problem was reported by a Health Professional from BRAZIL on Nov 12, 2007. Male patient, 39 years of age, was diagnosed with chronic myeloid leukaemia and was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: leprosy. HYDROXYCARBAMIDE dosage: unknown. Patient recovered.

Hydroxycarbamide Side Effects Report #5391592-7
Consumer or non-health professional from SINGAPORE reported HYDROXYCARBAMIDE problem on July 02, 2007. Female patient, 33 years of age, was diagnosed with essential thrombocythaemia and was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, muscular weakness, nail pigmentation, pancytopenia, vision blurred. HYDROXYCARBAMIDE dosage: unknown. During the same period patient was treated with ANAGRELIDE, BUSCOPAN, ALLOPURINOL, OMEPRAZOLE, SANGOBION. Patient recovered.

Hydroxycarbamide Side Effects Report #5391592-7
HYDROXYCARBAMIDE problem was reported by a Consumer or non-health professional from SINGAPORE on July 02, 2007. Female patient, 33 years of age, was diagnosed with essential thrombocythaemia and was treated with HYDROXYCARBAMIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, muscular weakness, nail pigmentation, pancytopenia, vision blurred. HYDROXYCARBAMIDE dosage: unknown. During the same period patient was treated with ANAGRELIDE, BUSCOPAN, ALLOPURINOL, OMEPRAZOLE, SANGOBION. Patient recovered.


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photosensitivity reaction, anaemia, leukopenia, malignant neoplasm progression, thrombocytopenia, , was diagnosed with glioblastoma multiforme and was diagnosed with polycythaemia vera, prophylaxis and