ADR that result in revision of patient information
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| Severe Skin Reactions associated with Xeloda (capecitabine) |
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Roche Hong Kong Limited (Roche), a licensed drug wholesaler, informed the Department of Health (DH) about important safety information for Xeloda (capecitabine) regarding severe skin reactions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), in some cases with fatal outcome, reported during treatment associated with Xeloda. Xeloda should be permanently discontinued in patients who experience a severe skin reaction possibly attributable to Xeloda treatment.
According to Roche, the frequency of severe skin reactions such as SJS and TENs is estimated as very rare taking into account the exposure to Xeloda as per April2013. TEN and SJS are considered to represent variants within a continuous spectrum of skin disorders characterized by generalized tender erythematous maculae progressing to blisters and denudation and often preceded by photophobia, symptoms of upper respiratory tract infection and fever. There is significant morbidity and mortality associated with severe skin reactions, especially for SJS and TEN. Morbidity and mortality may be reduced in patients where the suspect drug is stopped early compared to those where the suspect drug is carried on after the development of the blisters.
Health care providers should be aware of the potential causality of severe skin reactions and Xeloda treatment and be vigilant regarding such reactions to ensure prompt action and treatment. This includes discontinuation of Xeloda. Patients should be informed of the association and be made aware to seek medical advice should any symptoms of severe skin reactions occur.
In Hong Kong, Xeloda 150mg tablets (HK-46233) & Xeloda 500mg tablets (HK-46234)are registered by Roche and are prescription-only medicine. Informed by Roche, a Direct Healthcare Professional Communication is to be issued today to draw healthcare professional’s attention about the risk of severe skin reaction today. Besides, application to change the package insert of the products by including the relevant safety information will be submitted. DH has not received any adverse drug reaction against Xeloda so far and will keep vigilant on any safety updates of the drug.
Ends/ Monday, November 4, 2013
Issued at HKT 17:00
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