WHO Pharmaceuticals Newsletter 2003, No. 05
(2003; 15 pages) View the PDF document
Table of Contents
View the documentASTEMIZOLE - Withdrawn due to ventricular arrhythmias
View the documentBICALUTAMIDE - Withdrawn due to accelerated deaths
View the documentDACLIZUMAB - Warning about hypersensitivity reactions, increased mortality in cardiac transplant study
View the documentDANAZOL - Use restricted to second-line therapy in endometriosis
View the documentLEVACETYL-METHADOL - Product to be withdrawn due to adverse cardiac events; safer alternatives to be adopted
View the documentMOROCTOCOG ALFA - Reports of lack of effect in prophylaxis patients
View the documentNEFAZODONE - Sale discontinued due to adverse hepatic events
View the documentNIMESULIDE - Product under ‘special pharmacovigilance’
View the documentOSELTAMIVIR - Adverse reactions section to include acute renal failure, thrombocytopenia, leucopenia
View the documentPHENYLPROPAN-OLAMINE - New warnings on cardiovascular risks to be added
View the documentSOMATROPIN - Refused approval for use in AIDS-related wasting syndrome
View the documentTERFENADINE - Withdrawn due to ventricular arrhythmias
View the documentVALSARTAN - Reports of interstitial pneumonia
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE
Open this folder and view contentsMISCELLANY

DANAZOL - Use restricted to second-line therapy in endometriosis

UK. The use of danazol (Danol) has been restricted to second- line therapy in endometriosis and benign fibrocystic breast disease, as a result of safety and risk-benefit assessments suggesting that it may increase the baseline risk of ovarian cancer in patients being treated for endometriosis. The following indications have been removed from the Danol Summary of Product Characteristics (SPC): gynaecomastia, pre-operative thinning of the endometrium prior to surgery, dysfunctional uterine bleeding presenting as menorrhagia to control excessive blood loss and to control dysmenorrhoea, control of benign, multiple or recurrent breast cysts in conjunction with aspiration.

News & Updates, UKMi, 10 Sept 2003.
Available from URL:

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