Other safety alerts
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| Singapore: Update on strontium ranelate (Protos®): Risk of cardiac events and enhancing awareness of the local risk management plan to mitigate the risk of serious skin reactions |
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The Health Sciences Authority (HSA) would like to update healthcare professionals on two issues related to strontium ranelate (Protos®, Servier (S) Pte Ltd): (1) Risk of cardiac events raised by the European Medicines Agency (EMA); and (2) Enhancing awareness of the local risk management plan (RMP) to mitigate the risk of serious skin reactions.
Following the review by EMA, HSA had strengthened the local package insert (PI) to restrict the use of strontium ranelate to postmenopausal women with severe osteoporosis who were at high risk of fracture. As part of a new licensing condition to the company, HSA has also required that with effect from 1 January 2014, Servier will need to obtain the signed acknowledgement from doctors that they are aware of the risk of serious skin reactions and that they have received the Patient Medication Guide for distribution to their patients before the company can supply strontium ranelate to the respective clinics and hospitals. Healthcare professionals are advised to continue close monitoring of their patients for serious adverse events such as cardiac events and early signs of serious skin reactions.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../update_on_strontium.html
In Hong Kong, there is one registered pharmaceutical product Protos Granules For Oral Suspension 2g (HK-53835) containing strontium ranelate and it is a prescription-only medicine.
The safety concern on cardiovascular risk had been released by EMA and HSA and was posted on the Drug Office website on 13 April, 27 April and 7 August 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 15 April 2013. The registered package insert of Protos has been updated to include the above safety information. The Registration Committee of the Pharmacy and Poisons Board discussed the matter in the meeting in September 2013, and decided that the Department of Health should remain vigilant on the final version of the warnings by the European Union health authority and the final legally binding decision by the European Commission for further consideration.
Safety alerts on the risk of serious skin reactions had been released by HSA and EMA and was posted on the Drug Office website on 23 August 2011, 21 October 2011, 17 March 2012 and 18 July 2012, 30 August 2012 and 8 March 2013. Letters to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug were issued on 23 August 2011 and 19 March 2012. The registered package insert of Protos has been updated with safety warnings regarding serious skin reactions. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board and concluded in the meeting held in December 2012 that the Drug Office of the Department of Health to remain vigilant on any updated news of the drug for further consideration when necessary.
Ends/ Saturday, January 4, 2014
Issued at HKT 14:30
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