BPOM RI minta penghentian sementara peredaran obat sirop praxion terkait investigasi ginjal akut. Sebab, Kemenkes RI menemukan riwayat minum obat sirop praxion pada pasien terkonfirmasi ginjal akut.
Akurasi.id, Jakarta – Badan Pengawas Obat dan Makanan (BPOM RI) menghentikan sementara produksi dan peredaran obat penurun panas merek Praxion. Sebab, ditemukan riwayat minum obat sirup tersebut pada kasus kematian baru gagal ginjal akut progresif pada anak (GGAPA) DKI Jakarta.
Juru Bicara Kementerian Kesehatan Mohammad Syahril mengungkapkan, ada dua kasus baru gagal ginjal akut (acute kidney injury/AKI). Terdiri dari satu kasus konfirmasi dan meninggal dunia. Sementara, satu kasus suspek dan masih dalam perawatan.
Satu kasus konfirmasi gagal ginjal dialami oleh anak-anak berusia 1 tahun. Anak tersebut meninggal dunia setelah mengalami gejala gagal ginjal akut, termasuk tidak bisa kencing (anuria). Berdasarkan penelusuran, anak tersebut sempat minum sirup obat dengan merk Praxion.
“Satu Kasus konfirmasi gagal ginjal merupakan anak berusia 1 tahun, mengalami demam pada tanggal 25 Januari 2023, dan diberikan obat sirup penurun demam yang dibeli di apotek dengan merk Praxion,” kata Syahril dalam keterangan resmi, Senin (6/2/2023).
Kemenkes RI Investigasi Kasus Gagal Ginjal Akut
Berdasarkan temuan tersebut, Kemenkes RI masih melakukan pengujian sampel darah pada pasien untuk melihat penyebab pasti meninggalnya. Termasuk dugaan cemaran etilen glikol dan dietilen glikol di luar ambang batas aman pada obat sirop tersebut.
Dalam keterangan resmi BPOM RI, investigasi disebut sudah dilakukan. Pihak BPOM RI juga sudah berkomunikasi langsung dengan Kemenkes sejak 2 Februari 2023.
“Dalam rangka kehati-hatian. Meskipun investigasi terhadap penyebab sebenarnya kasus ini masih berlangsung, Badan Pengawas Obat dan Makanan (BPOM) sudah mengeluarkan perintah penghentian sementara produksi dan distribusi obat yang dikonsumsi pasien hingga investigasi selesai dilaksanakan,” tutur BPOM RI dikutip dari laman resminya sebagaimana melansir Detik.
“Terkait perintah penghentian sementara dari BPOM, industri farmasi pemegang izin edar obat tersebut telah melakukan voluntary recall (penarikan obat secara sukarela),” sambung keterangan itu.
Adapun beberapa hal yang diinvestigasi adalah sampel produk obat yang diminum pasien. Mereka juga menelusuri lebih lanjut bahan baku yang digunakan obat sirup tersebut.
“BPOM telah melakukan investigasi atas sampel produk obat dan bahan baku baik dari sisa obat pasien, sampel dari peredaran dan tempat produksi, serta telah diuji di laboratorium Pusat Pengembangan Pengujian Obat dan Makanan Nasional (PPPOMN). BPOM juga telah melakukan pemeriksaan ke sarana produksi terkait Cara Pembuatan Obat yang Baik (CPOB),” tulis keterangan tersebut.
Sebagai informasi, Adapun obat merk Praxion sebelumnya masuk dalam daftar obat yang aman dikonsumsi, yang dikeluarkan oleh Badan Pengawas Obat dan Makanan (BPOM). Obat tersebut masuk dalam tambahan 176 produk yang telah memenuhi ketentuan, sehingga total obat aman mencapai 508 produk sirup obat dari 49 Industri Farmasi (IF). (*)
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