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Teratogenicity has been demonstrated in mice, hamsters, cats, miniature swine, dogs, and monkeys at hydroxyurea doses that were within 1-fold of the human dose (based on mg/m2 dosing). The incidence of the adverse reactions calculated from pooled clinical trial data involving 824 patients and from post-marketing data are presented in the table below. In their assessment, the European regulators acknowledged weaknesses of the study, such as an unexpectedly low rate of cardiovascular events and the open-label design, which may lead to reporting bias. Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. Well I decided it's unusual to have problems in both knees and legs at the same time, varicose veins, thrombosis etc. Additional adverse events reported from worldwide postmarketing experience include fulminant hepatitis with fatal outcome, hypersensitive skin reactions (for example rash, erythema, exanthema and uticaria), edema, ileus/subileus, jaundice and/or hepatitis and associated liver damage, thrombocytopenia, and pneumatosis cystoides intestinalis (see PRECAUTIONS).
