European Union - The European Agency for the Evaluation of Medicinal Products (EMEA) has issued a public statement advising that anthracycline therapy should be avoided for 22 weeks following discontinuation of trastuzumab (Herceptin®).
While it is already established that concomitant use of trastuzumab and anthracyclines is associated with an increased risk of cardiotoxicity, data from an ongoing clinical study has indicated that the half-life of trastuzumab is now estimated to be approximately 25 days, rather than 5 - 6 days as previously believed. As such, an increased risk of cardiotoxicity with concomitant anthracyclines may exist.
EMEA advises that where a necessity for anthracycline therapy exists after stopping trastuzumab, careful monitoring of the patient’s cardiac function should be performed. Physicians are advised to continue to prescribe trastuzumab in accordance with the current approved prescribing information to ensure that patients receive adequate treatment.
Reference: Media Release, 19 June 2001. Available on http://www.eudra.org
Spontaneous monitoring systems are useful in detecting signals of relatively rare, serious and unexpected adverse drug reactions. A signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information”. All signals must be validated before any regulatory decision can be made. |
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