Page 154 - PENARIKAN PRODUK RANITIDIN YANG TERKONTAMINASI N-NITROSODIMETHYLAMINE (NDMA)

Judul : BPOM takes contaminated stomach drugs off market over
cancer risk

Nama Media : thejakartapost.com

Tanggal : 11 Oktober 2019
Halaman/URL: https://www.thejakartapost.com/news/2019/10/11/bpom-takes-
contaminated-stomach-drugs-off-market-over-cancer-risk.html

Tipe Media : Online

The Indonesian Food and Drug
Monitoring Agency (BPOM) has
suspended sales of drugs containing
ranitidine, commonly used to treat
stomach problems, following reports
from the United States and Europe
that the medication may be
contaminated with a carcinogenic
substance. The BPOM approved
ranitidine medicines, used to
decrease stomach acid production,
for sale in the country in 1989.

However, recent findings by the US Food and Drug Administration and the European
Medicine Agency (EMA) that ranitidine product samples contained a small amount of
N-Nitrosodimethylamine (NDMA) had prompted the agency to conduct a risk
assessment of all products containing ranitidine, the BPOM said in a statement on
Oct. 4. The agency cited a global study that determined the acceptable daily intake of
NDMA at 96 ng. An intake higher than that would be carcinogenic under long-term
consumption, meaning it would have the potential to cause cancer, the statement said.

There are 70 pharmacy firms producing ranitidine products [sold in Indonesia]. The
BPOM has run a [risk] assessment on some of the products and the results showed
that some of them have been found to contain NDMA amounts exceeding the limit
allowed for consumption.

We will recall these products. The assessment of all the products will be done in
stages," the agency's medicine registration director Lucia Rizka Andalucia told The
Jakarta Post on Thursday. As of Oct. 4, the agency had instructed a pharmacy firm,
PT Phapros Tbk or PEHA, to stop the production and distribution of its ranitidine
injection products found to have been contaminated with an unhealthy amount of
NDMA as well as recall its products already in the market.
PEHA said in a statement on Oct. 8 that it had recalled its ranitidine injection products
following BPOM's instruction since Oct. 3, and it had also stopped production and
distribution of said products since Sept. 25 after consulting with the agency. Three
other pharmacy firms have voluntarily recalled their products as of Oct. 4, namely PT
Glaxo Wellcome Indonesia with its Zantac injection products, PT Global Multi