Cegah Gagal Ginjal Anak, 5 Obat Sirup Ini Ditarik Peredarannya oleh BPOM
Bidan Kita – Badan Pengawas Obat dan Makanan (BPOM) akhirnya merilis nama 5 obat sirup yang ditarik peredarannya. Kelimanya ditarik karena dinilai memiliki kandungan cemaran Etilen Glikol (EG) dan Dietilen Glikol (DEG) yang melebihi ambang batas aman.
BPOM menyatakan bahwa penelusuran mereka menemukan bahwa mayoritas obat sirup yang beredar di masyarakat saat ini aman.
“Berdasarkan hasil pengawasan rutin BPOM yang dilakukan secara berkesinambungan, sirup obat yang beredar masih memenuhi persyaratan keamanan, khasiat, dan mutu,” kata BPOM dalam keterangan tertulis yang didapatkan Tempo, Kamis, 20 Oktober 2022.
Hal tersebut disimpulkan setelah BPOM melakukan pengujian dengan acuan Farmakope Indonesia dan acuan lain yang sesuai Undang-Undang Nomor 36 Tahun 2009 tentang Kesehatan sebagai standar baku nasional untuk jaminan mutu semua obat yang beredar.
Dalam keterangan tertulisnya, BPOM menyatakan telah melakukan sampling terhadap 39 bets dari 26 obat sirup yang diduga mengandung cemaran EG dan DEG. Hasilnya, terdapat 5 merk yang disebut memiliki kandungan EG dan DEG melampaui ambang batas aman. Mereka pun memerintahkan kepada pihak produsen untuk menarik peredaran obat tersebut.
5 Obat Sirup Yang Ditarik Peredarannya
Berikut daftar 5 obat sirup yang yang diperintahkan untuk ditarik peredarannya oleh BPOM:
1. Termorex Sirup (obat demam), produksi PT Konimex dengan nomor izin edar DBL7813003537A1, kemasan dus, botol plastik @60 ml.
2. Flurin DMP Sirup (obat batuk dan flu), produksi PT Yarindo Farmatama dengan nomor izin edar DTL0332708637A1, kemasan dus, botol plastik @60 ml.
3. Unibebi Cough Sirup (obat batuk dan flu), produksi Universal Pharmaceutical Industries dengan nomor izin edar DTL7226303037A1, kemasan Dus, Botol Plastik @ 60 ml.
4. Unibebi Demam Sirup (obat demam), produksi Universal Pharmaceutical Industries dengan nomor izin edar DBL8726301237A1, kemasan Dus, Botol @ 60 ml.
5. Unibebi Demam Drops (obat demam), produksi Universal Pharmaceutical Industries dengan nomor izin edar DBL1926303336A1, kemasan Dus, Botol @ 15 ml.
Pencemaran Dari 4 Bahan Tambahan Dalam Obat Sirup
BPOM menduga cemaran Etilen Glikol dan Dietilen Glikol tersebut berasal dari empat bahan tambahan yang digunakan dalam obat sirup tersebut. Empat bahan tambahan itu adalah propilen glikol, polietilen glikol, sorbitol, dan gliserin/gliserol.
Keempat bahan tersebut, menurut BPOM sebenarnya bukan merupakan bahan yang berbahaya atau pun dilarang penggunaannya dalam pembuatan obat sirup.
Belum Bisa Memastikan Sebagai Penyebab Gagal Ginjal Akut
Meskipun demikian, BPOM menyatakan belum dapat mendukung kesimpulan bahwa penggunaan obat sirup tersebut memiliki keterkaitan dengan kejadian gagal ginjal akut seperti isu yang beredar saat ini.
“Masih ada beberapa faktor risiko penyebab kejadian gagal ginjal akut seperti infeksi virus, bakteri Leptospira, dan multisystem inflammatory syndrome in children (MIS-C) atau sindrom peradangan multisistem pasca COVID-19,” tulis BPOM.
Sebelumnya Kementerian Kesehatan telah meminta tenaga kesehatan untuk tak memberikan obat dalam bentuk cair atau sirup. Hal itu dilakukan setelah banyaknya kasus gagal ginjal akut yang menyerang anak-anak secara misterius.
Hingga Selasa, 18 Oktober 2022, Kementerian Kesehatan menyatakan terdapat 206 anak dari 20 provinsi yang mengalami gagal ginjal akut. Sebanyak 99 anak diantaranya meninggal. Dugaan Kemenkes, anak-anak tersebut mengalami gagal ginjal karena menggunakan obat sirup. [ ]
Translate English:
To Prevent Kidney Failure in Children, These 5 Syrup Drugs Withdrawn from Circulation by BPOM
Bidan Kita – Food and Drug Supervisory Agency (BPOM) finally released the names of 5 syrup drugs that were withdrawn from circulation. The five were withdrawn because they were considered to have Ethylene Glycol (EG) and Diethylene Glycol (DEG) contamination that exceeded the safe threshold.
BPOM stated that their search found that the majority of syrup drugs circulating in the community today are safe.
"Based on the results of BPOM's routine monitoring carried out on an ongoing basis, the circulating medicinal syrups still meet the requirements for safety, efficacy, and quality," said BPOM in a written statement obtained by Tempo, Thursday, October 20, 2022.
This was concluded after BPOM conducted testing with references to the Indonesian Pharmacopoeia and other references in accordance with Law No. 36 of 2009 concerning Health as the national standard for quality assurance of all circulating drugs.
In a written statement, BPOM stated that it had sampled 39 batches of 26 syrup drugs suspected of containing EG and DEG contamination. As a result, there are 5 brands that are said to have EG and DEG content that exceeds the safe threshold. They also ordered the manufacturer to withdraw the circulation of the drug.
5 Syrup Drugs Withdrawn Circulation
The following is a list of 5 syrup drugs that were ordered to be withdrawn from circulation by BPOM:
1. Termorex Syrup (fever medicine), produced by PT Konimex with distribution license number DBL7813003537A1, box packaging, plastic bottle @60 ml.
2. Flurine DMP Syrup (cough and flu medicine), produced by PT Yarindo Farmatama with distribution permit number DTL0332708637A1, box packaging, plastic bottle @60 ml.
3. Unibebi Cough Syrup (cough and flu medicine), produced by Universal Pharmaceutical Industries with distribution license number DTL7226303037A1, Box packaging, Plastic Bottle @ 60 ml.
4. Unibebi Fever Syrup (fever medicine), produced by Universal Pharmaceutical Industries with distribution license number DBL8726301237A1, Box packaging, Bottle @ 60 ml.
5. Unibebi Fever Drops (fever medicine), produced by Universal Pharmaceutical Industries with distribution license number DBL1926303336A1, Box packaging, Bottle @ 15 ml.
Contamination from 4 additives in syrups
BPOM suspects that the Ethylene Glycol and Diethylene Glycol contamination comes from the four additives used in the syrup. The four additives are propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol.
The four ingredients, according to BPOM, are actually not hazardous materials nor are their use prohibited in the manufacture of syrup drugs.
Can't Be Sure As The Cause Of Acute Kidney Failure
However, BPOM stated that it could not support the conclusion that the use of the syrup has a relationship with the incidence of acute kidney failure, as is the current issue.
"There are still several risk factors that cause acute kidney failure, such as viral infection, Leptospira bacteria, and multisystem inflammatory syndrome in children (MIS-C) or post-COVID-19 multisystem inflammatory syndrome," wrote BPOM.
Previously, the Ministry of Health had asked health workers not to give drugs in liquid or syrup form. This was done after the many cases of acute kidney failure that mysteriously attacked children.
As of Tuesday, October 18, 2022, the Ministry of Health stated that 206 children from 20 provinces had acute kidney failure. A total of 99 children of them died. The Ministry of Health suspected that the children had kidney failure due to the use of syrup. [ ]
Source: tempo.co