According to global research, the longer antacid ranitidine is kept, the more NDMA it contains. NDMA is a known carcinogen. The Food and Drug Administration asked manufacturers to autonomously inspect products, and 10 batches now have to be removed from shelves.
Ranitidine is a common antacid that we now know contains carcinogen NDMA. The Food and Drug Administration says manufacturers have been ordered to test their products and the drug will be removed from shelves and recycled within a month.
(NDMA) levels are much higher than the recommended daily intake, so we asked China Chemical and Pharmaceutical to recall and recycle the product.
Recalls have been ordered for 10 batches, totaling 7.2 million tablets, with the batch numbers E720058, E720059, E720060, E720061, E720062, E720063, E720109, E720116, E720119, and E720120.
The batch numbers of these drugs are embossed, so they aren't that easy to read. The batch number can be found on the upper left corner. The government has so far ordered the recalls of 10 batch numbers. This one with this batch number, for example, does not need to be removed from shelves.
This is an old drug to begin with and there are many newer, better drugs with fewer side effects. Doctors have many alternatives they can prescribe.
According to the FDA, ranitidine has a 25 percent share in the domestic antacid market and the national health insurance program distributed over 80 million tablets in 2019. The license holders of the 19 other pharmaceutical products that contain ranitidine have been ordered to submit a safety report to the FDA before July 31. If they don't meet this deadline, they will have to stop selling their products.
就是這款專門用來治療胃灼熱、胃酸過多、十二指腸等醫師處方箋胃藥，叫做「悅擬停膜衣錠150毫克」，因為藥品成分「雷尼替丁」，被檢出有致癌疑慮的NDMA，因此食藥署要求廠商，從即日起下架停止供應，而且一個月內要完成回收。
食藥署藥品組研究員 洪秀勳表示：「它(NDMA)的含量，是高出了我們每日的攝取量，所以我們發文要求中化，它必須要做下市回收。」
食藥署表示，經藥廠自主檢驗確認，必須下架批號包括：E720058、E720059、E720060、E720061、E720062、E720063、E720109、E720116、E720119、E720120等，共10批，約720萬顆。
藥師公會全聯會發言人 黃彥儒表示：「這個藥品它的批號，是用鋼印打上去的，所以民眾其實不是很容易去看，在左上角這邊，有它的批號，政府目前公開有10個批號要下架。像這藥，這個批號，就是不用下架的批號。」
新光醫院胃腸肝膽科醫師 朱光恩表示：「這個藥，本來就是比較舊了嘛，那現在有很多新的藥，效果又比它好，副作用可能也沒那麼多。那麼我是覺得，醫師還有很多別的選擇可以用。」
而根據食藥署統計，這款藥品在全台胃藥市占率約1/4，健保108年使用量、約8千萬顆，至於其他也有使用"雷尼替丁"的19家藥品許可證持有商，必須在今年7月31號前，向食藥署提出安全評估報告，否則8月1號起、將暫停供應及販售。