Dear friends,
Someone in the E-Drug list asked me about the U.S. Food
and Drug Administration (FDA)'s reaction to the recent oral contraceptive
alert in the U.K. For those of you who are not familiar with the issue,
I will begin with the U.K. Committee on Safety of Medicines
(CSM) alert issued last month on the third-generation OCs namely desogestrel
and gestodene:
The CSM advice:
* Women taking OCs containing levonorgestrel, norethisterone, or
ethynodiol should be reassured that there is no need for them to change
their pill.
* Women taking OCs that include desogestrel or gestodene should be
strongly urged to complete their current cycle. The risks associated with
unwanted pregnancies are far greater than the risks of continuing these
pills.
* Third-generation OCs should not be used by women with risk factors for
venous thromboembolism.
* Third-generation OCs should be used only by women intolerant of other
combined OCs and prepared to accept an increased risk of thromboembolism.
[Ref: Choo V. Oral contraceptive alert in UK sparks off
controversy. Lancet Vol. 346 Oct 28, 1995 p.1149-1150)
In the interest of the E-Drug subscribers, I am responding to the general
list.
On November 14, 1995, the U.S. FDA issued the following statement:
" FDA has concluded from its review of three recent unpublished studies
that the risk is not great enough to justify switching to other products.
Gestodene is not approved in the U.S......
The use of combined OC has long been known to be associated with an
increased risk of blood clots. In the new unpublished studies, the
overall reported risk is lower than that reported in previous studies,
but the new studies indicate about a two-fold increase in the risk of
venous blood clots associated with products containing desogestrel and
gestodene as compared to products containing older progestins.
FDA will work with the manufacturers to update this information in the
product's labeling...... Women who are taking these products are advised
to discuss these contraceptives with their health care providers and make
an informed choice based on the benefits and individual preference......"
I hope the above is useful.
Kind regards.
Syed Rizwanuddin Ahmad
Researcher
Drug Safety, Education and Information
3831 Beecher Street, NW
Washington, DC 20007-1802, USA
Phone/Fax:1-202-965-1518
Email: srahmad@essential.org
November 18, 1995