At Health Canada's request, companies are strengthening product labels for certain strontium-containing natural health products with new restrictions, to minimize a possible increased risk of cardiovascular-related side effects (e.g., heart attack, stroke, blood clots) in people who are at risk of these types of events.
The label changes apply to strontium-containing products with a daily dose between 4 mg and 682 mg, which are used to help support bone mineral density. These products currently contain either strontium citrate, strontium gluconate or strontium lactate.
The new directions limit these products to users who have no history of, or risk factors for, heart disease, circulatory problems or blood clots. As well, consumers are advised to consult a healthcare practitioner for use longer than 6 months.
The measure follows a Health Canada safety review, a summary of which is available online. The review was undertaken in light of findings in Europe that led to restrictions for use of oral prescription drugs containing strontium at 680 mg/day (as strontium ranelate), due to the increased risk of cardiovascular events seen in patients who have risk factors for heart or circulatory-related side effects.
The Health Canada review found that there is no information available on the cardiovascular risk with strontium ranelate at levels lower than 680 mg/day, or with non-ranelate forms of strontium at any dose. No Canadian or international reports of cardiovascular side effects involving non-ranelate strontium products were identified at the time of the review. The review also found there is not enough information to compare how strontium ranelate is absorbed in the body relative to other, non-ranelate forms of strontium.
While uncertainties remain, Health Canada is using a precautionary approach and considers that strontium, regardless of the form it comes in or dose taken, may have a potential risk of cardiovascular side effects in people who are already at risk.
Health Canada continues to consider whether additional risk minimization measures may be needed to further restrict the use of strontium-containing products, particularly those products with higher daily doses. Measures under consideration include further changes to the directions for use or changing how certain strontium-containing products (e.g. with higher doses) are regulated so that they are available by prescription only, under the supervision of a healthcare professional.
Patients are advised of the following:
• Do not use a strontium-containing product if you have, or are at high risk for heart disease, circulatory problems, or blood clots. Risk factors include: a history of heart disease, heart attack, stroke, peripheral arterial disease, high blood pressure, high blood fat levels, diabetes, taking prescription hormone drugs, or if you are temporarily or permanently immobilized.
• If you have any cardiovascular risk factors, read the label of products you are taking to know if they contain strontium.
• Consult a healthcare practitioner for use beyond six months.
• Talk to a healthcare practitioner if you have questions or if you are unsure whether these products are appropriate for you.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../55524a-eng.php
In Hong Kong, there is one registered pharmaceutical product containing strontium ranelate, namely Protos Granules for Oral Suspension 2g (HK-53835), and is a prescription-only medicine registered by Servier Hong Kong Ltd. Safety alerts regarding risk of cardiovascular and cerebrovascular events associated with strontium had been issued by various drug regulatory authorities, and were posted on the Drug Office website since 2013, with the last update posted on 16 July 2014. Letters to inform local healthcare professional of the risk were issued on 19 March 2012 and 15 April 2013. So far, the Department of Health (DH) has not received any adverse drug reaction case on strontium. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee) in September 2013, February 2014, and May 2014. The Committee decided that the registered package insert of Protos should be updated to include the appropriate safety information. The DH will remain vigilant on any safety updates on the drug.
Ends/ Friday, October 23, 2015
Issued at HKT 15:00
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