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DAFTAR PUSTAKA

Badan POM. 2007. Informasi Aspek Keamanan Obat Rosiglitazone: Efek Samping Kardiovaskular.
Berita MESO Vol. 25, No. 2, November 2007.ISSN : 0852-6184.
Badan POM. 2010. Pembekuan Izin Edar Obat Antidiabetes yang Mengandung Rosiglitazone.
Berita MESO Vol. 28, No. 2, November 2010. ISSN : 0852-6184.
Badan Pengawas Obat dan Makanan Republik Indonesia, Leaflet Obat Antidiabetika Oral
Badan Pengawas Obat dan Makanan Republic Indonesia, 2008, Informatorium Obat Nasional
Indonesia 2008, Jakarta
Bloomgarden ZT. Approaches to Treatment of Type 2 Diabetes. Diabetes Care2008; 31 1697-1703
Data Badan POM
David J. Graham. et al,. Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in
Elderly Medicare Patients Treated with Rosiglitazone or Pioglitazone. JAMA. 2010; 304 (4):
411-418
Data Badan POM RI
EMA, Press Release, EMEA Statement on recent publication on cardiac safety of rosiglitazone, 23
Mei 2007
EMA, EMA Question and Answers on the suspension of rosiglitazone-containing medicines, 23
September 2010.
FDA News, U.S. Food and Drug Administration, 21 May 2007 (www.fda.gov)
Glaxo Smith Kline. 2014. MEDICATION GUIDE AVANDIA(ah-VAN-dee-a) (rosiglitazone
maleate) tablets Research Triangle Park, NC 27709.U.S. Food and Drug Administration.
Hawkins M, Rossetti L. Insulin Resistance and Its Role in the Pathogenesis of Type 2 Diabetes. In :
Kahn CR, King GL, Moses AC, Weir GC, Jacobson AM, Smith RJ (Eds) Joslins Diabetes
Mellitus. Lippincott Williams & Wilkin. Philadelphia. Pg 425-448, 2005.
Leahy JL. -cell Dysfunction in Type 2 Diabetes In : Kahn CR, King GL, Moses AC, Weir GC,
Jacobson AM, Smith RJ (Eds) Joslins Diabetes Mellitus. Lippincott Williams & Wilkin.
Philadelphia. Pg 449-462, 2005
Nathan MN, Buse JB, Mayer BD, Ferrannini E, Holman RR, Sherwin R et al. Medical management
of Hyperglycemia in Type 2 Diabetes A consebsus Algorithm for the Initiation and
Adjustment of Therapy. A consensus statement of the American Diabetes Association and the
European Association for the Study of Diabetes. Diabetes Care2008; 31:1-11.
Nissen SE, Wolski K. An Updated Meta-Analysis of Risk for Myocardial Infarction and
Cardiovascular Mortality. Arch Intern Med 2010; 170 (14): 1191-1201.
Peraturan Kepala Badan Pengawas Obat Dan Makanan Republik Indonesia Nomor
Hk.04.1.33.12.11.09938 Tahun 2011 Tentang Kriteria Dan Tata Cara Penarikan Obat Yang
Tidak Memenuhi Standar Dan/AtauPersyaratan
SDI, Vector One: Total Patient Tracker (TPT). January 2010-October 2010. Data extracted 12-15-10
US FDA, FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and
cardiovascular safety, 22 Februari 2010.
US FDA, FDA News Release: FDA significantly restrics access to the diabetes drug Avandia, 23
September 2010.

US FDA, FDA News Release, FDA adds Boxed warning for heart-related risk to Anti-Diabetes Drug
Avandia, 14 November 2007.
WHO Pharmaceuticals Newletter, No. 3, 2007.
www. pom.go.id

LAMPIRAN

Lampiran 1.Press Release BPOM tentang pembekuan izin edar obat Rosiglitazone

Lampiran 2.Form Kuning untuk Formulir Pelaporan Efek Samping Obat

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