Assalamu'alaikum wr.wb.
Pak Kartono Mohamad yang terhormat,
Terimakasih karena telah merespon pertanyaan saya tentang herbal beberapa waktu yang lalu. Kali ini saya mohon kembali Bapak sudi menjawab pertanyaan saya. Apakah izin BPOM RI itu lebih tinggi kedudukannya dari izin Departemen Kesehatan pada suatu produk? Atau bagaimana sebenarnya prosedur perizinan tersebut. Hal ini saya tanyakan karena saya menemukan produk tertentu yang ada izin BPOM-nya, tapi saya belum menemukan izin Depkesnya.
Terimakasih
Wassalamu'alaikum wr.wb.
Mustari
--- Pada Sab, 25/9/10, Kartono Mohamad <kmjp47@indosat.net.id> menulis:
Dari: Kartono Mohamad <kmjp47@indosat.net.id>
Judul: [Dokter Umum] FDA approves contraceptive with folate
Kepada: dokter-ina@yahoogroups.com, "Dokter Umum Milist" <dokter_umum@yahoogroups.com>, desentralisasi-kesehatan@yahoogroups.com
Tanggal: Sabtu, 25 September, 2010, 9:18 AM
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.
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