ADR that result in revision of patient information
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| Singapore: Risk of atypical fracture with Prolia® (denosumab) |
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GlaxoSmithKline (GSK) would like to notify healthcare professionals of the risk of atypical femoral fracture with Prolia®. Cases of atypical femoral fracture have been confirmed in patients receiving Prolia® participating in the ongoing open-label extension study of the pivotal phase 3 fracture trial in postmenopausal osteoporosis (FREEDOM). These events have occurred very rarely (<1/10,000) based on 31,266 subject-years exposed to Prolia® in bone loss studies. To communicate this important information, the Prolia® package insert has been updated with a new warning on atypical femoral fracture and inclusion of atypical femoral fracture as an adverse drug reaction.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../DHCPL.html
In Hong Kong, Prolia Solution For Injection in Pre-filled Syringe 60mg/ml (USA) [HK-60588] and Prolia Solution For Injection in Pre-filled Syringe 60mg/ml (The Netherlands) [HK-60589] are registered by GlaxoSmithKline Limited and are prescription-only medicines Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. On 6 Sep 2012, GlaxoSmithKline Limited has informed Department of Health that a Dear Healthcare Professional letter will be sent to healthcare providers concerning the risk of atypical femoral fracture and updated information are being made to the package insert of these two products. The applicationsfor approval to change the package inserts are under process.
Ends/ Saturday, October 20, 2012
Issued at HKT 12:00
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