PRAC recommends suspending use of Protelos and Osseor (strontium ranelate)
13.01.2014
The European medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos and Osseor should no longer be used to treat osteoporosis.
In April 2013 EMA had recommended restricting the use of Protelos and Osseor to reduce the risk of heart problems. On the 17 April 2013 (in Croatian) HALMED reported about it on its webpages. On the 20 May 2013 (in Croatian), a Dear Healthcare Professional Letter was sent out to healthcare professionals. 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 on the benefits and risk of the medicine. It was noted that for every 1,000 patient-years 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 and Osseor than with placebo. In addition, Protelos and Osseor are associated with a number of other risks, such as serious skin reactions, disturbances in consciousness, seizures, hepatitis (liver inflammation) and reduced number of blood cells.
The PRAC 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 and osseor have 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 medicinal products against the known risks and concluded that the balance was no longer favourable and recommended Protelos and 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.
The information about this PRAC recommendation is available on the EMA webpages, or here.
HALMED has received in total 24 suspected adverse reaction reports to strontium ranelate, seven of which were related to skin, seven to neurological and one to blood adverse reactions; the other reports were related to other symptoms not encompassed by the PRAC review. In 23 out of 24 reports, patients have recovered from adverse reactions, whereas in one case (where a heaviness in stomach and diarrhoea has been reported) the outcome has not been known. Out of 24 reports, 9 have been considered serious. Among serious adverse reactions, three have been related to heart adverse reactions (atrium fibrillation, supraventricular extrasystole and arrhythmia) and two to heavy skin reactions (angioedema and bullous dermatitis).
