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Review Hydroxyurea Safety Reports submitted to FDA

Total Hydroxyurea reports: 19.
Hydroxyurea FDA safety alerts: 2006 .
Reported deaths: 1    Reported hospitalizations: 9.
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FDA Reported Hydroxyurea Side Effects: anaemia, skin ulcer, asthenia, thrombocythaemia, confusional state, pyrexia, rash erythematous, delusion, blood pressure decreased, anxiety, agitation.
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Hydroxyurea Side Effects Report #5619831-5
Physician from CANADA reported HYDROXYUREA problem on Feb 06, 2008. Male patient, 64 years of age, weighting 108.0 lb, was diagnosed with glioblastoma multiforme, brain oedema and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: abasia, agitation, anaemia, anxiety, asthenia, blood pressure decreased, confusional state, delusion. HYDROXYUREA dosage: 500 MG, BID. During the same period patient was treated with GLEEVEC, DECADRON, DILANTIN, CLOBAZAM. Patient was hospitalized. Patient died on 09/19/2006.

Hydroxyurea Side Effects Report #5627695-9
HYDROXYUREA problem was reported by a Health Professional from UNITED STATES on Feb 14, 2008. Female patient, 79 years of age, weighting 170.0 lb, was diagnosed with platelet count increased and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: pain in extremity, poisoning, skin ulcer. HYDROXYUREA dosage: unknown. Patient recovered.

Hydroxyurea Side Effects Report #5638242-X
Consumer or non-health professional from UNITED STATES reported HYDROXYUREA problem on Feb 12, 2008. Female patient was diagnosed with platelet count increased and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: anaemia, anorexia, asthenia, chills, dizziness, enuresis, fatigue, hypersomnia, memory impairment. HYDROXYUREA dosage: unknown. During the same period patient was treated with ATENOLOL, CADUET, COUMADIN, GLYBURIDE, METFORMIN. Patient recovered.

Hydroxyurea Side Effects Report #5570275-4
HYDROXYUREA problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 19, 2007. Female patient, 71 years of age, weighting 120.0 lb, was diagnosed with platelet count increased and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: burning sensation, joint swelling, vasculitis. HYDROXYUREA dosage: 500MG 1X A DAY ORAL. Patient was hospitalized. Patient recovered.

Hydroxyurea Side Effects Report #5514121-3
Health Professional from UNITED KINGDOM reported HYDROXYUREA problem on Nov 12, 2007. Male patient, 35 years of age, was diagnosed with thrombocythaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: azoospermia. HYDROXYUREA dosage: unknown. Patient recovered.

Hydroxyurea Side Effects Report #5514129-8
HYDROXYUREA problem was reported by a Health Professional from DENMARK on Nov 08, 2007. Male patient, 72 years of age, was diagnosed with essential thrombocythaemia, cardiomegaly, gastritis, prophylaxis, benign prostatic hyperplasia, hypokalaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: fall, pneumonia, pneumothorax. HYDROXYUREA dosage: unknown. During the same period patient was treated with ASPIRIN, FUROSEMIDE, ESOMEPRAZOLE, ALLOPURINOL, ALFUZOSIN, POTASSIUM CHLORIDE. Patient was hospitalized. Patient recovered.

Hydroxyurea Side Effects Report #5520317-7
Physician from UNITED STATES reported HYDROXYUREA problem on Nov 15, 2007. Female patient was diagnosed with essential thrombocythaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: nausea, treatment noncompliance, vomiting. HYDROXYUREA dosage: unknown. Patient recovered.

Hydroxyurea Side Effects Report #5521826-7
HYDROXYUREA problem was reported by a Consumer or non-health professional from GERMANY on Nov 15, 2007. Female patient, 79 years of age, was diagnosed with essential thrombocythaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: nail discolouration, nausea, skin ulcer. HYDROXYUREA dosage: unknown. Patient recovered.

Hydroxyurea Side Effects Report #5530233-2
Physician from GERMANY reported HYDROXYUREA problem on Nov 27, 2007. Female patient, 72 years of age, weighting 138.9 lb, was diagnosed with myeloproliferative disorder and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: angioedema, condition aggravated, glossodynia, rheumatoid arthritis, thrombocythaemia, urticaria. HYDROXYUREA dosage: unknown. Patient recovered.

Hydroxyurea Side Effects Report #5531357-6
HYDROXYUREA problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on Nov 13, 2007. Male patient, 74 years of age, was diagnosed with chronic myeloid leukaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, abdominal distension, blood pressure decreased, dyspnoea, haemodialysis, haemoglobin decreased, metabolic acidosis, renal failure acute, respiratory rate increased. HYDROXYUREA dosage: 500 MG (FOUR TIMES A DAY) ORAL. During the same period patient was treated with ALLOPURINOL. Patient was hospitalized. Patient recovered.

Hydroxyurea Side Effects Report #5478438-3
Health Professional from UNITED KINGDOM reported HYDROXYUREA problem on Oct 03, 2007. Female patient, 67 years of age, weighting 119.0 lb, was diagnosed with essential thrombocythaemia, hypertension and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: anaemia, bone marrow failure. HYDROXYUREA dosage: unknown. During the same period patient was treated with CANDESARTAN CILEXETIL, ASPIRIN, RAMIPRIL. Patient recovered.

Hydroxyurea Side Effects Report #5482225-X
HYDROXYUREA problem was reported by a Physician from GERMANY on Oct 05, 2007. Female patient, 67 years of age, weighting 198.4 lb, was diagnosed with myelodysplastic syndrome and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: erythema, panniculitis. HYDROXYUREA dosage: unknown. Patient was hospitalized. Patient recovered.

Hydroxyurea Side Effects Report #5449573-0
Pharmacist from UNITED STATES reported HYDROXYUREA problem on Sept 10, 2007. Female patient was diagnosed with chronic myeloid leukaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: renal tubular acidosis, renal tubular disorder. HYDROXYUREA dosage: 1000MG M- TH 500 MG TU,WED,FRI,SAT, SUN. Patient was hospitalized. Patient recovered.

Hydroxyurea Side Effects Report #5452649-5
HYDROXYUREA problem was reported by a Physician from SWITZERLAND on Sept 13, 2007. Male patient, 81 years of age, was diagnosed with myeloproliferative disorder and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: arthralgia, oedema peripheral, rash erythematous. HYDROXYUREA dosage: unknown. During the same period patient was treated with ASPIRIN, ENATEC, TORSEMIDE, PANTOPRAZOLE, XATRAL. Patient was hospitalized. Patient recovered.

Hydroxyurea Side Effects Report #5466670-4
Health Professional from UNITED STATES reported HYDROXYUREA problem on Sept 24, 2007. Male patient, 47 years of age, weighting 196.0 lb, was diagnosed with polycythaemia vera and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: abdominal pain. HYDROXYUREA dosage: 500 MG 1 PO QD. Patient recovered.

Hydroxyurea Side Effects Report #5416497-4
HYDROXYUREA problem was reported by a Health Professional from SWEDEN on Aug 13, 2007. Female patient, 77 years of age, was diagnosed with anaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: anaemia, thrombocythaemia. HYDROXYUREA dosage: unknown. During the same period patient was treated with DUROFERON. Patient recovered.

Hydroxyurea Side Effects Report #5419669-8
Health Professional from SWEDEN reported HYDROXYUREA problem on Aug 20, 2007. Female patient, 77 years of age, was diagnosed with anaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: anaemia, thrombocythaemia. HYDROXYUREA dosage: unknown. During the same period patient was treated with DUROFERON. Patient recovered.

Hydroxyurea Side Effects Report #5385429-X
HYDROXYUREA problem was reported by a Physician from UNITED STATES on July 06, 2007. Male patient, weighting 52.91 lb, was diagnosed with sickle cell anaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: anaemia, b precursor type acute leukaemia, pain, pyrexia, thrombocytopenia. HYDROXYUREA dosage: 500 MG QD ORAL. Patient was hospitalized. Patient recovered.

Hydroxyurea Side Effects Report #5385429-X
Physician from UNITED STATES reported HYDROXYUREA problem on July 06, 2007. Male patient, weighting 52.91 lb, was diagnosed with sickle cell anaemia and was treated with HYDROXYUREA. After drug was administered, patient experienced the following problems/side effects: anaemia, b precursor type acute leukaemia, pain, pyrexia, thrombocytopenia. HYDROXYUREA dosage: 500 MG QD ORAL. Patient was hospitalized. Patient recovered.


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abasia, agitation, anaemia, anxiety, asthenia, blood pressure decreased, confusional state, delusion, , was diagnosed with glioblastoma multiforme, brain oedema and was diagnosed with platelet count increased and