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EU panel recommends suspension of risky bone disease drug
Jan 10, 14 FDA warningsEuropean regulators have recommended suspending a popular bone-building drug made by unlisted French firm Servier because of the risk of serious heart problems and blood clots.
The European Medicines Agency had already restricted the use of Protelos - also known as Osseor or strontium ranelate - last April but its pharmacovigilance committee said on Friday the drug should no longer be used to treat osteoporosis at all.
The move follows an analysis which found 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 among patients taking the drug than those on placebo.
The recommendation will now be sent to the agency’s Committee for Medicinal Products for Human Use, which is expected to issue a final opinion at its January 20-23 meeting.
(Reporting by Ben Hirschler; Editing by Pravin Char)
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