Safety advice on particular drugs or classes of drugs
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| European Union : Outcome of Periodic Safety Update Report assessment leads to recommendation to restrict use of Protelos/Osseor (strontium ranelate) |
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions in the use of Protelos/Osseor (strontium ranelate) based on the outcome of a routine benefit-risk assessment of the medicine, showing an increased risk of heart problems, including heart attacks.
Protelos and Osseor are identical medicines used in the treatment of osteoporosis. The data from clinical studies showed that there was an increased risk of a heart attack in post-menopausal women taking Protelos/Osseor compared with those taking placebo (a dummy treatment), although there was no increase in deaths. On the whole, the data were of concern given other serious risks (blood clots and rare serious skin reactions) that were identified in a previous EMA review in 2012. The PRAC therefore concluded that a further expedited in-depth evaluation of the benefits and risks of the medicine is needed. While this evaluation is carried out, the PRAC recommends that changes should be implemented to the prescribing information for Protelos/Osseor. The need for a further evaluation and the following changes to the product information will be considered by the CHMP:
- Protelos/Osseor should only be used for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture and severe osteoporosis in men at increased risk of fracture.
- Protelos/Osseor should not be used in patients with current or past history of ischaemic heart disease (such as angina or a heart attack), peripheral arterial disease (obstruction of large blood vessels, often in the legs) or cerebrovascular disease (diseases affecting the blood vessels supplying the brain, such as stroke).
- Protelos/Osseor should not be used in patients with hypertension (high blood pressure) that is not adequately controlled by treatment.
The outcome of the PRAC assessment will be sent to the Agency’s Committee for Medicinal Products for Human Use (CHMP), which will adopt a final opinion at the next CHMP meeting of 22 to 25 April 2013.
Please refer to the following website at EMA for details :
http://www.ema.europa.eu/../news_detail_001759.jsp&mid=WC0b01ac058004d5c1
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. Safety alerts to mitigate risks of serious skin reactions following use of strontium had been released by HSA and EMA. In view of EMA’s action, a letter to healthcare professionals about the new safety information will be issued. Drug Office will remain vigilant on any updated news of the drug and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, April 13, 2013
Issued at HKT 12:00
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