Final Opinion on Possible Suspension of Strontium Ranelate to Be Made in February

The recommendation of the European Medicine Agency's Pharmacovigilance Risk Assessment Committee that strontium ranelate (Protelos and Osseor) should no longer be used to treat osteoporosis is still under consideration by the Committee for Medicinal Products for Human Use (CHMP). At its January 2014 meeting the Committee requested additional information from the company to inform its scientific decision making. A final opinion will be made by the CHMP at its meeting in February 2014. http://www.nos.org.uk/

What’s Behind the EMA’s Possible Suspension of Strontium Ranelate?

Here’s the official explanation:

"The EMA’s recommendations are based on an analysis of pooled data from randomized studies in about 7,500 post-menopausal women with osteoporosis. The results showed an increase in the risk of heart attack with Protelos/Osseor as compared with placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% confidence interval, 1.07 to 2.38). There was also an imbalance in the number of serious heart events seen with the medicine in two other studies, one in men with osteoporosis and another in patients with osteoarthritis. No increased risk in mortality was observed."

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001774.jsp&mid=WC0b01ac058004d5c1

The increased risk of heart attacks did not show up in the clinical trials of strontium ranelate, but it did show up in this analysis of pooled dated from the trials. The results showed a relative risk of 1.6 for heart attacks for the group on Protelos/Osseor compared to placebo. That result means someone taking strontium ranelate has a 60 percent higher risk of heart attacks than someone not taking the drug. That is quite significant.

Another reason the European Medicines Agency is considering suspending strontium ranelate may be that the EMA is worried about the possibility of experiencing with strontium ranelate what the French experienced with Mediator, a drug manufactured by Servier, which also manufactures strontium ranelate. The Mediator scandal became one of France’s biggest medical scandals of recent years. French health experts now believe that Mediator, developed for treating overweight diabetics, could have killed between 500 and 2,000 people between 1976 and November 2009, when it was finally banned for causing heart valve problems and deaths. These numbers are disputed by Servier, which says there are only three documented cases where death can be clearly attributed to Mediator. In other cases, it says, aggravating factors were at work.

http://www.bbc.co.uk/news/world-europe-12155639

A final reason some believe is behind the EMA’s recommendations and possible suspension is simply costs. Strontium ranelate is much more expensive than alendronate (alendronic acid, generic Fosamax) for osteoporosis.

 

Strontium Ranelate Prescriptions May Be Suspended in the European Union

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that strontium ranelate (Protelos/Osseor) no longer be used to treat osteoporosis. 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 on January 20-23, 2014.

After further examination of the data, the PRAC noted that there were four or more cases of both cardiac events and thromboembolism with strontium ranelate for every 1000 patient-years compared with placebo. Moreover, the drug is also associated with other adverse events, including serious skin reactions, disturbances in consciousness, seizures, liver inflammation, and reduced numbers of red blood cells.

Although strontium ranelate does prevent about five nonspinal fractures, 15 spinal fractures, and 0.4 hip fractures for every 1000 patient-years, the committee decided that these benefits did not outweigh the potential risks and therefore the product's use should be suspended until further data support a benefit in a defined patient group.

In April 2013, the PRAC advised restrictions on use of the product, and those restrictions were endorsed by CHMP.

Servier, the manufacturer of strontium ranelate, acquired the patent rights to market strontium malonate everywhere except in the United States, where Osteologix retained the rights. Perhaps, now, Servier will be more inclined to develop and market strontium malonate, which may not have the problems associated with strontium ranelate. However, this is a possibility for the future, not the present.

Strontium citrate, which also may not have the problems associated with strontium ranelate, is currently an option for any patient in the EU who wants to continue taking strontium, if strontium ranelate use is suspended.  I have been taking strontium citrate continuously for six years with no problems.