Strontium Ranelate to Remain Available in EU

As of February 21, 2014, the European Medicines Agency (EMA) has concluded its review of strontium ranelate (Protelos/Osseor). The EMA is recommending the medication remain available in the European Union (EU) but further restricting its use to patients who cannot be treated with other medicines approved for osteoporosis due to contraindications or intolerance. These patients should continue to be evaluated regularly by their doctor, and treatment should be stopped if patients develop heart or circulatory problems. Patients with established, current or past history of ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or those with uncontrolled hypertension should not use the medicine.

Study data showed a beneficial effect in preventing fractures, including in patients at high risk of fracture. Available data do not show evidence of an increased cardiovascular risk with Protelos/Osseor in patients who did not have a history of heart or circulatory problems.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002031.jsp&mid=WC0b01ac058004d5c1

 

 

Strontium and Your Heart

A committee of the European Medicines Agency (EMA) has recommended the following restrictions in the use of strontium ranelate (sold in the European Union under the brand names Protelos and Osseor) to reduce the risk of adverse cardiac events:

1a. Strontium ranelate 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 for fracture.

2a.Strontium ranelate should not be used in patients with current or past history of ischemic heart disease (such as angina or MI), peripheral arterial disease (PAD), or cerebrovascular disease.

3a.Strontium ranelate should not be used in patients with hypertension that is not controlled by treatment.

http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/human/000560/WC500142021.pdf

What, if anything, should those of us taking strontium citrate do?

Here is what I think.

1b. Strontium citrate can be used as a supplement by men and women with osteopenia or osteoporosis. (I believe the first restriction on strontium ranelate is mostly for cost containment because bisphosphonates, especially the generic equivalents, are much cheaper than strontium ranelate.) 

2b. Strontium citrate can be used UNDER MEDICAL SUPERVISION in patients with current or past history of ischemic heart disease, PAD, or cerebrovascular disease.

    3b. Strontium citrate should not be used in patients with uncontrolled hypertension. Patients must get their hypertension under control by medication. Strontium citrate can be used UNDER MEDICAL SUPERVISION in patients with hypertension that is controlled by treatment.