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Ottawa, ON—A
recent news story on CBC’s Disclosure may have scared
many users of Diane®-35 (cyproterone acetate) into stopping
medication without consulting their doctors, according to The Society
of Obstetricians and Gynaecologists of Canada.
The segment,
Two-for-One, aired January 14, 2003. It is also the subject of a
web feature on the CBC website.(1)
“Regrettably,
the Disclosure feature chose to sensationalize an incomplete
scientific report submitted as a letter to The Lancet(2)
in October 2001, which claimed that Diane®-35 caused more blood
clots than other oral contraceptives,” said Robert Reid, MD,
Chairperson of the SOGC’s National Contraceptive Awareness
Program. “That study failed to take into account other characteristics
of women who take Diane®-35 that could explain most, if not
all, of the reported differences.”
The Lancet letter prompted Health Canada to issue an advisory(3)
(December 19, 2002) that cyproterone acetate is indicated only for
severe acne and hirsutism. Health Canada has not approved the therapy
for use as a contraceptive, and Berlex Canada says that Diane®-35
is not marketed as a contraceptive. Although Disclosure, reported
that the majority of the 800,000 prescriptions written in Canada
for the therapy last year were for (non-indicated) birth control,
the SOGC noted that cyproterone acetate is used as an oral contraceptive
by women in more than 50 countries.
“All oral contraceptives raise the risk of blood clots very
slightly (from four per 100,000 non-users per year to approximately
12 to 16 per 100,000 users per year),” said Donna Fedorkow,
MD, President of the SOGC.
Greater risk with pregnancy
“The risk is no greater than the one of developing blood clots
from smoking cigarettes or being overweight, and it is much lower
than the risk of developing blood clots during pregnancy. A more
comprehensive study reported in 2002(4) examined the risks of blood
clots in all oral contraceptive users in Denmark between 1994 and
1998. This report indicated the risk of blood clots associated with
Diane®-35 was no greater than that with other oral contraceptives,”
she said.
“It is unfortunate that news stories are often developed for
their sensational merit rather than their scientific accuracy,”
said André Lalonde, MD, Executive Vice-President of the SOGC.
“And in this case we are very concerned that the Disclosure
story, by selective reporting and by failing to put risks and benefits
of Diane®-35 into perspective, may have put Canadian women at
risks for unintended pregnancy.”
For more information
1.Two-for-One. "CBC News: Disclosure." CBC television.
January 14, 2003. Avaliable at <http://cbc.ca/disclosure/archives/030114_diane/main.
html>. Accessed February 7, 2003.
2. Vasilakis-Scaramozza C, Jick H. Risk of venous thromboembolism
with cyproterone or levonorgestrel contraceptives. The Lancet
2001;358(9291):1427-1429.
3. http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/advisory/tpd/diane-35_e.html
4. Lidegaard Ø, Edström B, Kreiner S. Oral contraceptives
and venous thromboembolism a five-year national case-control study.
Contraception 2002;65:187-196.
Additional reading
Campodonico F, Carmignani G. Risk of venous thromboembolism and
oral contraceptives. The Lancet April 13, 2002;359:1348.
Compel A, Carpentier S, Francès C, Plette JC. Risk of venous
thromboembolism and oral contraceptives. The Lancet April
13, 2002;359:1348.
Fedorkow D, Barber K. In Response. JOGC April 2003;4(25):270-273.
Mills A. Combined oral contraception and the risk of venous thromboembolism.
Hum Reprod 1997;12(12):2595-2598.
Debate: Venous thromboembolism and the pill. Hum Reprod 1998;13(5):1115-1120.
Debate: Venous thromboembolism and the pill. Hum Reprod 1998;14(1):7-10.
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