International studies have determined that with time, gastric drugs containing ranitidine have a chance of developing unsafe levels of NDMA, an impurity that is classified as a probable human carcinogen. As around 80 million tablets of gastric drugs are consumed in Taiwan each year, the Taiwan Food and Drug Administration (TFDA) in a July 30 press release said that with the advice of experts, physicians will be prohibited from prescribing all drugs containing ranitidine beginning Aug. 1, while remaining stock will be recalled from shelves of pharmacies, pharmaceutical distributors and medical institutions and disposed of.
Hung Kuo-teng, chief of the TFDA’s Medicinal Products Division, said that drugs containing ranitidine are used to treat heartburn, indigestion, excess gastric acid secretion and duodenal ulcers, among other gastric conditions. Typically, these drugs have a shelf life of two to four years. However, experts have found that the longer these drugs are stored and/or if they are stored at above room temperature, the amount of NDMA in these drugs could increase and exceed the acceptable daily intake of 96 nanograms.
According to Division Chief Hung, Taiwan has approved 36 licenses for drugs containing ranitidine, including 29 prescription drugs and seven instruction drugs. Annual consumption of drugs containing ranitidine covered by National Health Insurance is estimated at around 80 million tablets. Given that a considerable amount of drugs containing ranitidine are consumed each year, continued use of these drugs could lead to widespread health risks. As replacement options for ranitidine are readily available, the TFDA has decided to issue an across-the-board recall of products containing ranitidine. Manufacturers looking to resume selling ranitidine drugs must conduct safety tests to ensure that their products do not produce excess amounts of NDMA within the stated shelf lives.
The TFDA also reminds the public that those prescribed ranitidine drugs should not halt or interrupt their treatment regimens and should consult their physicians for replacement options if they have concerns. Those who have purchased ranitidine drugs at drugstores without a prescription are advised to temporarily stop taking the medication.
[2020-07-30 / CNA]
