Editor's Comment

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EDITORS COMMENT

Year : 2010 | Volume : 1 | Issue : 2 | Page : 62

Editor's Comment

Rama Vaidya, Rashmi Shah
,

Date of Web Publication

28-Jan-2011

Correspondence Address:
Rama Vaidya
,

PMID: 21716765

How to cite this article:
Vaidya R, Shah R. Editor's Comment. J Mid-life Health 2010;1:62

How to cite this URL:
Vaidya R, Shah R. Editor's Comment. J Mid-life Health [serial online] 2010 [cited 2013 Jun 20];1:62. Available from: http://www.jmidlifehealth.org/text.asp?2010/1/2/62/76279

Dr. Jyotsna Potdar reports an occurrence of breast cancer in a patient who was on Tibolone treatment for five years. It was an observational study of 50 women on Tibolone therapy for a period of six months to five years. Cause-effect relation between Tibolone treatment and breast cancer cannot be derived from such an uncontrolled /observational study. However, the Million Women Study has concluded that current use of Tibolone significantly increased RR (1.45 [1.25-1.68], P<0.0001) and was associated with an increased risk of incident and fatal breast cancer. ^[1] Use of Tibolone for treating vasomotor symptoms in breast cancer survivors is also contraindicated as an interim analysis of the LIBERATE trial found a 40% increase in the risk for breast cancer recurrence with Tibolone. ^[2] Isolated spontaneously reported cases of adverse drug reaction generated early signals that may get established or refuted by larger case control studies or randomized double-blind placebo-controlled clinical trials. McPherson and Hemminski point out the importance of recording rare adverse events during efficacy trials, as they might be early signals of true drug-related adverse events. ^[3] Spontaneous reporting will continue to be an important tool for identifying rare adverse reactions which are sometimes difficult to identify in premarketing clinical trials. ^[4]

References

1.	Beral V. Million Women Study Collaborators. Breast cancer and hormonereplacement therapy in the Million Women Study. Lancet 2003;362:419-27.
2.	Kenemans P, Bundred NJ, Foidart JM, Kubista E, von Schoultz B, Sismondi P, et al. Safety and efficacy of tibolone in breast-cancer patients with vasomotor symptoms: A double-blind, randomised, non-inferiority trial. Lancet Oncol 2009;10:135-46.
3.	McPherson K, Hemminski E. Synthesizing licensing data to assess drug safety. BMJ 1997;328:518-20.
4.	Pillans PI. Clinical perspectives in drug safety and adverse drug reactions. Expert Rev Clin Pharmacol 2008;1:695-705

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