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. 
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