New oral contraceptive risks
July 11, 2011
ORAL contraceptive pills
containing the progestogen
drospirenone pose a greater risk of
venous thromboembolism (VTE) to
women, than oral contraceptives
containing the progestogen
levonorgestrel, according to two
recent studies.
The new studies, which compared
the VTE risk in women taking oral
contraceptives containing
drospirenone to ones containing
levonorgestrel, found that
drospirenone pills have a two- to
three-fold increase in their VTE risk
profile compared to their
levonorgestrel counterparts.
As a result of the findings, the
Therapeutic Goods Administration
undertook a review of the VTE risks
associated with the oral
contraceptive pills registered for
use in Australia that contain
drospirenone, Bayer’s Yaz and
Yasmin.
In considering the evidence, the
TGA found that the two new
studies had a “number of
limitations, including a lack of
information on confounding
factors”.
As such, the agency concluded
that whilst all oral contraceptives
pose a small risk of VTE, it had no
plans to remove or restrict the sale
of Yaz or Yasmin.
The TGA also said that it is
working with Bayer to amend the
product information for Yaz and
Yasmin to incorporate the new
evidence, and that it would
continue to closely monitor and
assess all new information and take
whatever regulatory action is
required to protect the safety of
consumers.
MEANWHILE the Head of
Regulatory Affairs at Bayer Australia
and New Zealand, Elizabeth
Thompson, said the company fully
supports the review of the data by
the TGA, “as patient safety is an
absolute priority for the
pharmaceutical company”.
“A large body of evidence shows
the overall risk of venous
thromboembolism due to
drospirenone-containing oral
contraceptives remains
unchanged,” she said.
“Bayer is working with the TGA to
implement minor amendments to
the product information for
drospirenone-containing oral
contraceptives.
“Our priority is the safety of
patients and the quality use of
medicine,” she added.
The above article was sent to subscribers in Pharmacy Daily's issue from 11 Jul 11To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 11 Jul 11
