MHRA restricts Protelos indications and adds new cardiovascular warnings

In light of cardiovascular safety concerns, the MHRA has limited use of the osteoporosis treatment Protelos (strontium ranelate) to severe cases of osteoporosis.

The reduction in bone density seen in osteoporosis increases the risk of a fracture occurring | SCIENCE PHOTO LIBRARY
The reduction in bone density seen in osteoporosis increases the risk of a fracture occurring | SCIENCE PHOTO LIBRARY

To minimise the risk of serious heart problems, Protelos (strontium ranelate) should now only be used for severe osteoporosis in postmenopausal women at high risk of fracture and men at increased risk of fracture.

Analysis of randomised controlled trial data has shown that strontium is associated with an increased risk of myocardial infarction and other serious cardiac disorders (relative risk 1.6 vs placebo [95% CI 1.07–2.38]).

The MHRA advises that strontium should only be started by a physician experienced in the treatment of osteoporosis. Clinicians should assess cardiovascular risk before starting strontium and at regular intervals during treatment and should base their decision to prescribe the drug on the individual patient’s risks.

In addition, strontium is now contraindicated in patients with ischaemic heart disease, peripheral artery disease or cerebrovascular disease (or a history of these conditions) and in those with uncontrolled hypertension. Treatment should be stopped if any of these conditions develop.

The prescribing advice for strontium was previously changed after concerns about an increased risk of venous thromboembolism and serious skin reactions arose in March 2012.

View Protelos drug record

MHRA Drug Safety Update April 2013

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