Other safety alerts
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| European Union: Recommendation to restrict the use of Protelos/Osseor (strontium ranelate) |
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The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended a restriction in the use of the osteoporosis medicine Protelos/Osseor, following an assessment of data showing an increased risk of serious heart problems. The CHMP recommended that Protelos/Osseor should only be used to treat severe osteoporosis in postmenopausal women at high risk of fracture and severe osteoporosis in men at increased risk of fracture. Additional measures, including restrictions in patients with heart or circulatory problems, were also recommended to minimise the heart risks of these medicines. The CHMP recommendation is based on the advice of the Pharmacovigilance Risk Assessment Committee (PRAC), which evaluated Protelos/Osseor as part of a routine benefit-risk assessment. During the assessment, data from clinical studies in post-menopausal women were evaluated, showing a higher risk of heart attack with Protelos/Osseor than with placebo, with no observed increase in mortality risk. Given the other serious risks (blood clots and rare serious skin reactions) previously identified with the medicine, the PRAC concluded that certain restrictions in the use of the medicine should be in place for the benefit-risk balance to remain favourable and that a further in-depth evaluation of the benefits and risks of the medicine was needed. The CHMP agreed with the PRAC's recommendations and this opinion will be sent to the European Commission for a legally binding decision.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/docs/en_GB/../WC500142507.pdf
In Hong Kong, there is one registered product Protos Granules For Oral Suspension 2g (HK-53835) containing strontium ranelate and is a prescription-only medicine. The safety concern on the cardiovascular risk has been released by the EMA and was posted on the website of Drug Office on 13 April 2013, and a letter to healthcare professionals was issued on 15 April 2013. As reported on 13 April 2013, the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board, and the Department of Health will remain vigilant on any updated news of the drug.
Ends/Saturday, April 27, 2013
Issued at HKT 12:00
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