其 他 安 全 警 示
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| Sinagpore: Association of venous and arterial thromboembolism with thalidomide and lenalidomide (Revlimid®) (English Only) |
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HSA would like to update healthcare professionals on the association of venous and arterial thromboembolic events with lenalidomide and thalidomide. From a recent review of overseas post-marketing data, it was observed that patients treated with thalidomide had an increased risk of arterial thromboembolism, in addition to the established risk of venous thromboembolism. The combination of lenalidomide and dexamethsaone has also been associated with an increased risk of venous and arterial thromboembolism (predominantly deep vein thrombosis, pulmonary embolism, MI and cerebrovascular accident). A review of the Celgene pharmacovigilance database found that a total of 493 medically confirmed reports of arterial thromboembolic events associated with lenalidomide have been received. Healthcare professionals are advised to take into consideration the above safety information, the presence of venous and arterial thromboembolic risk factors (eg, smoking, hypertension, hyperlipidaemia) as well as the need for thrombo-prophylaxis, when evaluating if their patients are suitable for treatment with thalidomide or lenalidomide.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/product_safety_alerts/safety_alerts_2011.html
In Hong Kong, lenalidomide is registered as Revlimid Cap 5mg, 10mg, 15mg and 25mg, they are registered by Celgene Ltd and are prescription-only medicines. According to our record, there is no registered pharmaceutical product containing thalidomide. The safety information of a possible increased risk of developing new malignancies with lenalidomide were released by the US FDA and the UK MHRA and were posted on the website of Pharmaceutical Service on 9 April and 5 May 2011. A letter to inform healthcare professionals was issued on 9 April 2011. In view of the new safety information on the association of venous and arterial thromboembolic events, a letter to inform healthcare professionals will be issued.
Ends/ Tuesday, August 23, 2011
Issued at HKT 17:00
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