TGA Protos black box
April 4, 2014
Servier has updated the product
information of Protos (strontium
ranelate) following a Therapeutic
Goods Administration (TGA) review.
Protos was the subject of a review
in early Feb (PD 05 Feb), following
a decision by the European
Medicines Agency (EMA) to further
restrict the use of the osteoporosis
medication to use only in patients
who cannot be treated with other
medicines.
A black box warning has been
added to the product information
for the medication, which is in line
with the EMA’s recommendation
that Protos only be used when
other medications for osteoporosis
were considered unsuitable.
The black box warning relegates
the product to second-line
use and re-emphasises the
contraindications and precautions,
and highlights the need for regular
monitoring.
Other sections of the PI and the
Consumer Medicines Information
(CMI) have also been updated to
spotlight these elements.
Servier Australia said healthcare
professionals would receive
updated information on the
prescribing information.
It quoted Osteoporosis Australia
medical director Professor Peter
Ebeling as saying that, for patients
who met the revised criteria,
strontium ranelate remained an
effective therapy, particularly for
those at high fracture risk.
Pharmacists can refer patients to
the new information by CLICKING
HERE.
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