EMA pharmacovigilance unit calls for suspension of Protelos/Osseor

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor (strontium ranelate), from independent French drugmaker Laboratoires Servier, should no longer be used to treat osteoporosis.

Last spring, the Agency recommended restricting the use of Protelos/Osseor to reduce the risk of heart problems (The Pharma Letter April 12, 2013). 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 there were four more cases of serious heart problems (including heart attacks) and four more cases of blood clots or blockages of blood vessels with Protelos/Osseor than with placebo. 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.