WHO Pharmaceuticals Newsletter 2002, No. 02
(2002; 18 pages) View the PDF document
Table of Contents
View the documentEDITORIAL
Close this folderREGULATORY MATTERS
View the documentACARBOSE - Revised precautions for Acarbose and others (Japan)
View the documentCYPROTERONE WITH ETHINYLESTRADIOL - Risk of venous thromboembolism (New Zealand)
View the documentENOXAPARIN SODIUM - Important changes to injection product labelling (USA)
View the documentHERBAL DIETARY SUPPLEMENTS (PC-SPES & SPES) - Adulteration with prescription only medicines precipitates regulatory action (Canada, Ireland, USA)
View the documentHUA FO - Sildenafil detected in tablets (Canada)
View the documentINTERFERON ALFA 2B, RECOMBINANT - Safety related labelling change (USA)
View the documentKAVA-KAVA - Further investigations into Piper methysticum and liver injury (New Zealand, Canada, Ireland, USA)
View the documentNEFAZODONE - New black box warning to report rare cases of liver failure (USA)
View the documentORAL CONTRACEPTIVES - Risk of cervical cancer with long-term use in women with high risk type of HPV (UK)
View the documentPAROXETINE - Withdrawal symptoms can be severe (USA)
View the documentSODIUM PHOSPHATES ORAL SOLUTION - Risk of electrolyte shift if maximum dose is exceeded (Canada)
View the documentTAMOXIFEN - Prevention in breast cancer versus risks of thromboembolic events (UK)
View the documentZIPRASIDONE HCl - Warnings and contraindications sections strengthened (USA)
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUG OF CURRENT INTEREST
View the documentADVERSE DRUG REACTIONS (ADR) - ASSOCIATIONS
Open this folder and view contentsFEATURE
View the documentEVENTS & ANNOUNCEMENTS
 

TAMOXIFEN - Prevention in breast cancer versus risks of thromboembolic events (UK)

UK. Tamoxifen is already a widely used hormonal treatment for women following treatment for early and advanced breast cancer. Now, in addition to its use as a treatment in cancer, preliminary results from the International Breast Cancer Intervention Study (IBIS) provide evidence also for the use of tamoxifen to ‘prevent’ breast cancer in healthy women at high risk. The results so far show that the incidence of breast cancer was reduced by one-third in women at high risk, compared to women taking a placebo. The study also indicated, however, that tamoxifen can increase the risk of thromboembolism, particularly during and immediately after major surgery or periods of immobility. The UK Department of Health has sent out an urgent communication with the above information to all directors of public health. The key messages in the communication may be summarised as under:

1. It is clear that the benefits for women being treated for breast cancer with tamoxifen far outweigh the risks. It is important that women taking the drug as a treatment continue to do so as there is overwhelming evidence that tamoxifen saves life among women with breast cancer. There is evidence of some increase in risk from thromboembolism with tamoxifen, especially during and immediately after major surgery or periods of immobility. Patients should be made aware of the symptoms of venous thromboembolism and if they have any sudden onset of breathlessness they should consult their doctor immediately.

2. The IBIS study gives evidence of the preventative action of tamoxifen in breast cancer. However this is not a use of tamoxifen that has yet been licensed except in the context of a trial.

3. A full analysis of all trials needs to be carried out to consider whether the benefits of preventative action outweigh potential risks.

Reference:

Urgent Communication from Chief Medical Officer, 27 Mar 2002.
Available from URL: http://www.mca.gov.uk

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Last updated: May 3, 2013