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."
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.
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.
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