Osteoporosis: EU recommends suspending use of Protelos/Osseor (strontium ranelate) drug (2014-01-13)

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor should no longer be used to treat osteoporosis.

 

 

In April 2013 the Agency had recommended restricting the use of Protelos/Osseor to reduce the risk of heart problems. These recommendations were the result of a routine benefit-risk assessment and it was also decided at the time that there was a need for a further in-depth review.

The PRAC has now conducted an in-depth review taking into account available data on the benefits and risks of the medicine. The Committee noted that for every 1,000 patient-years (equivalent to 1,000 patients being treated for 1 year) there were 4 more cases of serious heart problems (including heart attacks) and 4 more cases of blood clots or blockages of blood vessels with Protelos/Osseor than with placebo (a dummy treatment).
In addition, Protelos/Osseor is associated with a number of other risks, such as serious skin reactions, disturbances in consciousness, seizures (fits), liver inflammation and reduced number of blood cells.

The Committee also questioned the evidence on the extent to which the restrictions recommended in April 2013 reduced the cardiovascular risk and how well the restrictions work in clinical practice, particularly as the medicine is used for long-term treatment in elderly patients.

With regard to its benefits, Protelos/Osseor has been shown to have a modest effect in osteoporosis, preventing about 5 non-spinal fractures, 15 new spinal fractures and 0.4 hip fractures for every 1,000 patient-years.

The PRAC weighed the benefits of the medicine against the known risks and concluded that the balance was no longer favourable and recommended Protelos/Osseor be suspended until there are new data showing a favourable balance in a defined patient group.

The PRAC recommendation will now be sent to the Agency’s Committee for Medicinal Products for Human Use (CHMP), which is expected to issue the Agency’s final opinion at its meeting of 20 to 23 January 2014.

More about the medicine

Protelos/Osseor (strontium ranelate) is authorised in the EU to treat severe osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and who are at high risk of fracture (broken bones) in the spine and the hip. It is also used to treat severe osteoporosis in men who are at increased risk of fracture.

This is a summary of the European public assessment report (EPAR) for Protelos and for Osseor.

Protelos is a medicine that contains the active substance strontium ranelate. It is available as 2-g sachets containing granules that are made up into an oral suspension.
The medicine can only be obtained with a prescription.

Osseor is a medicine that contains the active substance strontium ranelate. It is available as 2 g sachets containing granules that are made up into an oral suspension.
The medicine can only be obtained with a prescription.

For more information
The European Medicines Agency

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