Other safety alerts
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| European Union: PRAC recommends suspending use of Protelos/Osseor (strontium ranelate) |
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The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor should no longer be used to treat osteoporosis. In April 2013 the Agency had recommended restricting the use of Protelos/Osseor to reduce the risk of heart problems. These recommendations were the result of a routine benefit-risk assessment and it was also decided at the time that there was a need for a further in-depth review.
The PRAC has now conducted an in-depth review taking into account available data on the benefits and risks of the medicine. The Committee noted that for every 1,000 patient-years1 there were 4 more cases of serious heart problems (including heart attacks) and 4 more cases of blood clots or blockages of blood vessels with Protelos/Osseor than with placebo (a dummy treatment). In addition, Protelos/Osseor is associated with a number of other risks, such as serious skin reactions, disturbances in consciousness, seizures (fits), liver inflammation and reduced number of blood cells.
The Committee also questioned the evidence on the extent to which the restrictions recommended in April 2013 reduced the cardiovascular risk and how well the restrictions work in clinical practice, particularly as the medicine is used for long-term treatment in elderly patients. With regard to its benefits, Protelos/Osseor has been shown to have a modest effect in osteoporosis, preventing about 5 non-spinal fractures, 15 new spinal fractures and 0.4 hip fractures for every 1,000 patient-years.
The PRAC weighed the benefits of the medicine against the known risks and concluded that the balance was no longer favourable and recommended Protelos/Osseor be suspended until there are new data showing a favourable balance in a defined patient group. The PRAC recommendation will now be sent to the Agency’s Committee for Medicinal Products for Human Use (CHMP).
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/docs/en_GB/../WC500159375.pdf
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, 7 August 2013 and 4 Jan 2014. 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.
Further to the PRAC recommendation to suspend the use of Strontium ranelate, 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, Jan 11, 2014
Issued at HKT 12:30
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