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26 September 2010

Re: [Dokter Umum] FDA approves contraceptive with folate

 

Dr Alim, seharusnya saya yang belajar dari dokter Alim.
Tentunya kalau memmpelajari Disaster Medicine tidak hanya
soal triase tetapi juga belajar PTDS (Post Traumatic
Depression Syndrome) ya? Selamat belajar tetapi dengan doa
mudah-mudahan tidak ada disaster di Indonesia (mana
mungkin?). Atau kalau ada disaster tidak banyak korbannya,
terutama karena sudah ada dokter ahli disaster medicine.
Selamat belajar. Cewek Itali banyak yang cantik.
KM

----Original Message----
From: dr.alim@ymail.com
Date: 26/09/2010 12:52
To: <dokter_umum@yahoogroups.com>
Subj: Re: [Dokter Umum] FDA approves contraceptive with
folate

Wah diforum ini ada dr.Kartono ya?

Kenalkan dok saya Alim, yunior yg di Jogja, sedang
memperdalam Disaster Medicine di Italy, dlm program
European Master in Disaster Medicine.

Mohon arahannya dok.

Alim-Jogja

dr.alim@ymail.com

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-----Original Message-----

From: "Kartono Mohamad" <kmjp47@indosat.net.id>

Sender: dokter_umum@yahoogroups.com

Date: Sat, 25 Sep 2010 09:18:24

To: <dokter-ina@yahoogroups.com>; Dokter Umum
Milist<dokter_umum@yahoogroups.com>; <desentralisasi-
kesehatan@yahoogroups.com>

Reply-To: dokter_umum@yahoogroups.com

Subject: [Dokter Umum] FDA approves contraceptive with
folate

September 24, 2010 — The US Food and Drug Administration
(FDA) today

approved an oral contraceptive — the first of its kind —
that is intended

both to prevent pregnancy and reduce the risk for neural
tube defects in

their offspring if and when they give birth.

The new contraceptive, Beyaz (Bayer HealthCare
Pharmaceuticals), contains

levomefolate calcium, a metabolite of folic acid that
helps produce and

maintain new cells in the body. Low folate levels in women
have been linked

with neural tube defects in their children such as spina
bifida, resulting

in recommendations that women of childbearing age
supplement their diet with

folate.

"Combining an oral contraceptive with folate is important,
because women may

become pregnant during [oral contraceptive] use or shortly
after

discontinuation, possibly before seeking preconception
counseling from their

healthcare provider," said Dr. Anita Nelson, professor of
obstetrics and

gynecology at the Harbor–University of California at Los
Angeles Medical

Center, Torrance, California, in a company press release.
"For women who

want to use an oral contraceptive, Beyaz offers a new
option for women to

receive daily folate supplementation."

The approval is based on the already-approved oral
contraceptive

drospirenone/ethinyl estradiol (Yaz, Bayer HealthCare
Pharmaceuticals),

which contains the same doses of estrogen and progestin.

Like Yaz, Beyaz is approved for:

Preventing pregnancy

Treating symptoms of premenstrual dysphoric disorder
(PMDD) in women who

choose to prevent pregnancy with an oral contraceptive

Treating moderate acne vulgaris in women at least 14 years
old who desire an

oral contraceptive for birth control

For women who choose an oral contraceptive as their method
of birth control,

Beyaz is also approved for raising folate levels to reduce
the risk for

neural tube defects in offspring.

Beyaz increased folate levels in women who participated in
a multicenter,

double-blind, randomized, controlled US trial designed to
determine product

efficacy. In a Germany study, folate levels remained
elevated for several

weeks after Beyaz was discontinued.

Beyaz safety and efficacy data for the contraception,
PMDD, and acne

indications came from previous clinical trials of Yaz.

The FDA said that the clinical trials of Beyaz did not
yield any findings

that would suggest it differs from Yaz in terms of its
overall safety

profile. The agency expects that the most common adverse
events for Beyaz

will be the same as those for Yaz. Adverse effects most
frequently reported

by users of combined oral contraceptives are irregular
uterine bleeding,

nausea, breast tenderness, and headaches.

As with other oral contraceptives, Beyaz is not intended
for use in women

older than 35 years who smoke.

More information about today's FDA announcement is
available on the agency's Web site.

[Non-text portions of this message have been removed]

[Non-text portions of this message have been removed]

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