Other safety alerts
|
| |
| Updates on the use of Protelos/Osseor (strontium ranelate) |
| |
1. European Union: Recommendation on Protelos/Osseor (strontium ranelate) to remain available but with further restrictions
The European Medicines Agency (EMA) has concluded its review of Protelos/Osseor (strontium ranelate) and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis. In addition these patients should continue to be evaluated regularly by their doctor and treatment should be stopped if patients develop heart or circulatory problems, such as uncontrolled high blood pressure or angina. As recommended in a previous review, patients who have a history of certain heart or circulatory problems, such as stroke and heart attack, must not use the medicine.
These final recommendations from the Agency’s Committee for Medicinal Products for Human Use (CHMP) come after initial advice from the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the medicine due to its cardiovascular risk. The Committee concluded that given the benefits seen in preventing fractures in patients at high risk, Protelos/Osseor should remain an option for patients with no history of cardiovascular disease who cannot take other medicines.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002031.jsp&mid=WC0b01ac058004d5c1
2. United Kingdom: Press release: New advice on osteoporosis medicine to be issued
The related news was also reported at Medicines and Healthcare Products Regulatory Agency (MHRA) website.
Following a European review, the Medicines and Healthcare products Regulatory Agency (MHRA) will be issuing updated advice to healthcare professionals that Protelos (strontium ranelate), used to treat severe osteoporosis in post-menopausal women and men with a high risk of fracture, should only be prescribed to patients who do not have a history of heart problems and if the patient is unable to take other medicines for this condition.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON382706
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. Safety alerts regarding the cardiovascular risk, venous thromboembolism and severe skin reactions associated with strontium had been released by various regulatory authorities and were posted on the Drug Office website. Letters to inform healthcare professionals to draw their attention on the relevant issues and urge them to report any adverse drug reaction related to the drug were issued on 23 August 2011, 19 March 2012 and 15 April 2013. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee) in December 2012 and September 2013. The Committee decided that the registered package insert of Protos should include the appropriate safety information and 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.
Further to the PRAC recommendation to suspend the use of Strontium ranelate reported on 11 January 2014 and this final recommendation from CHMP to remain the drug available but with further restrictions, the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board. The Department of Health will remain vigilant on any safety updates of the drug.
Ends/ Saturday, February 22, 2014
Issued at HKT 12:30
|
| |
|
