Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
July 30, 2020
Reporter Wu Liang-yi / Taipei Report
Pharmaceutical products containing "ranitidine" were previously found to contain the impurity "NDMA," a potential human carcinogen. The Food and Drug Administration (FDA) announced today that starting August 1, all medications containing this ingredient will be banned. These drugs account for over 80 million doses used annually.
After collecting domestic and international safety assessment data to evaluate the clinical benefits and risks, the FDA determined that the N-nitrosodimethylamine (NDMA) impurity content in ranitidine medications increases with prolonged storage or storage at temperatures above room temperature. This could lead to NDMA levels exceeding the daily acceptable intake limit of 96ng.
The FDA noted that alternative medications are available domestically and has requested pharmaceutical companies, pharmacies, and medical institutions to suspend the supply, sale, or use of ranitidine-containing drugs starting August 1.
The 36 affected medications are all stomach drugs, including 29 prescription drugs and 7 over-the-counter drugs, available in forms such as film-coated tablets and injections. Ranitidine-containing drugs are primarily used for conditions like heartburn, acid-related indigestion, excessive stomach acid, and duodenal ulcers.
The FDA advises patients prescribed these medications by a doctor not to discontinue use without consulting their physician, as doing so may affect treatment. Those with concerns should discuss alternative options with their doctor. For individuals who purchased these drugs over the counter at pharmacies or drugstores, the FDA recommends temporarily stopping use.
Source: https://health.ltn.com.tw/article/breakingnews/3244153
36 Stomach Medicines with Carcinogenic 'Ranitidine' Banned Next Month by FDA
Reporter Wu Liang-yi / Taipei Report
Pharmaceutical products containing "ranitidine" were previously found to contain the impurity "NDMA," a potential human carcinogen. The Food and Drug Administration (FDA) announced today that starting August 1, all medications containing this ingredient will be banned. These drugs account for over 80 million doses used annually.
After collecting domestic and international safety assessment data to evaluate the clinical benefits and risks, the FDA determined that the N-nitrosodimethylamine (NDMA) impurity content in ranitidine medications increases with prolonged storage or storage at temperatures above room temperature. This could lead to NDMA levels exceeding the daily acceptable intake limit of 96ng.
The FDA noted that alternative medications are available domestically and has requested pharmaceutical companies, pharmacies, and medical institutions to suspend the supply, sale, or use of ranitidine-containing drugs starting August 1.
The 36 affected medications are all stomach drugs, including 29 prescription drugs and 7 over-the-counter drugs, available in forms such as film-coated tablets and injections. Ranitidine-containing drugs are primarily used for conditions like heartburn, acid-related indigestion, excessive stomach acid, and duodenal ulcers.
The FDA advises patients prescribed these medications by a doctor not to discontinue use without consulting their physician, as doing so may affect treatment. Those with concerns should discuss alternative options with their doctor. For individuals who purchased these drugs over the counter at pharmacies or drugstores, the FDA recommends temporarily stopping use.
Source: https://health.ltn.com.tw/article/breakingnews/3244153