Caution with combined OCs
February 15, 2013
HEALTH professionals need to
weigh patient needs against the
possible increased risk of venous
thromboembolism when
considering combined oral
contraceptives containing new
generation progestogens, according
to NPS.
The comments follow the TGAs
announcement that it will review
combined oral contraceptives
containing new-generation and
anti-androgenic progestogens,
given data which has surfaced
indicating that some newer (oral)
contraceptives carry a higher risk of
VTE than older drugs.
“It is well established that oral
contraceptives carry a small risk of
VTE - much lower than the risk of
VTE during pregnancy and during
the postpartum period,” said NPS
MedicineWise clinical advisor
Andrew Boyden.
“The risk will differ according to
the generation of combined oral
contraceptive, and increasingly
evidence suggests that oral
contraceptives containing newer
synthetic progestogens carry a
higher risk of VTE.
“So when choosing an oral
contraceptive, or when considering
Diane-35 or its generics for the
treatment of acne, health
professionals should weigh the risks
of VTE against the clinical needs of
their patients and take care
especially in women with risk
factors for venous or arterial
thrombosis including obesity or
smoking,” he added.
The TGA’s move comes shortly
after the EMA announced that it
would review combined oral
contraceptives based on French
data, which resulted in France's
National Agency for the Safety of
Medicines and Health Products
(MSNA) suspension of the Diane 35
and its generics (combined OCs
used in the treatment of acne).
“After evaluation of all available
data, MSNA estimated that the
benefit/risk of Diane 35 and its
generic is unfavorable in the
treatment of acne, especially in
view of the risk of venous
thromboembolism,” a statement
from the MSNA said.
“In addition, the extensive use of
these drugs as contraceptives is not
consistent and their effectiveness
as a contraceptive has not been
demonstrated by appropriate clinical
studies,” the statement added.
According to the MSNA, the data
showed the risk of
thromboembolism including
venous thromboembolism risk was
four times higher than women who
do not take these treatments.
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