Information Update - Strontium health products: New restrictions to address possible heart and circulatory-related risks

OTTAWA, Oct. 22, 2015 /CNW/ - 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.  Health Canada will keep Canadians informed of new actions regarding these products.

What you should do:

• 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.

Report health or safety concerns:

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Affected Products

Product Name	Company	Natural Product Number (NPN)
Advanced Bone Protection + Strontium	Advanced Orthomolecular Research Inc.	80039417
Albi Naturals Strontium	Bona Vita Holdings Inc.	80055877
Bone Rescue	Bel Marra Nutritionals Inc.	80044149
Doctor's Best Strontium Bone Maker	Doctor's Best, Inc.	80047402  (licence cancelled*)
Joint Flex Pain Free and Rejuvenate Capsules	Hanan Enterprise	80040343
Medivin	Vital Pharmaceuticals	80048534
Organika Health Products Inc. Strontium Capsules	Organika Health Products Inc.	80044406
Organika Health Products Inc. Strontium Capsules	Organika Health Products Inc.	80046325
Phyto D 1000	North American Pharmacal, Inc.	80050488  (licence cancelled*)
Strontium	Optimum Health Choices Inc.	80053986
Strontium (Citrate)	Pure Encapsulations Inc.	80039416
Strontium Citrate	New Roots Herbal Inc.	80047772
Strontium Lactate	Advanced Orthomolecular Research Inc.	80028095
Strontium Plus	Platinum Naturals	80024004  (licence cancelled*)
Strontium Plus	Platinum Naturals	80054481
Strontium Support II	Advanced Orthomolecular Research Inc.	80039461

*Licences for these products have been cancelled by the company and product labels will not be revised. Products with cancelled licences will be permitted to remain on the market until stock runs out.

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone]; Public Inquiries: [phone], 1-866 225-0709