Lately, Carcinogens have found their way into the generic drug supply of the United States. In 2018, FDA found NDMA, a probable carcinogen for humans, in the widely-used valsartan tablets due to the impurities it had in it.
A similar case developed recently when CVS Pharmacy, a subsidiary of American health and retail company CVS Health, reportedly announced that it has suspended sales of CVS Health brand and Zantac brand ranitidine products until any further notice over a possible link to cancer.
The pharmaceutical firm took this action out of abundance of caution because of the recent Product Alert issued by the Food and Drug Administration (FDA) about ranitidine products containing low levels of NDMA (nitrosodimethylamine), which is a known animal carcinogen and a probable carcinogen in humans.
Reports cite, Zantac’s official recall has not been issued yet. The FDA has not yet recommended patients to stop the consumption of ranitidine presently.
The FDA is currently working to examine if the low levels of NDMA present in ranitidine products are a risk to patient life. The NDMA levels found by FDA in ranitidine from primary tests hardly exceeds the amount of NDMA present in common foods. However, the company claims, people wishing to return their products can return them for a refund.
The FDA stated that people consuming these medicines shouldn't panic, but it also suggested to switch on any other over-the-counter drug alternative to ranitidine while it would test more samples.
Ranitidine is a H2 Blocker that is consumed to get relief from heartburn. The company would continue selling of other H2 Blockers, which would include Tagamet, Pepcid as well as its respective generic equivalents, cimetidine and famotidine.
Another pharmaceutical firm Novartis had already announced that it would no longer supply Zantac’s generic versions because of the discovery.
Sandoz, a subsidiary of Novartis that prepares generic version of Zantac stated that it has not received any reports regarding adverse events pertaining to the use of the drug as a part of the aforementioned recall. It also stated that patients should approach their respective physician and/or pharmacy for any alternative treatment option.
Sanofi, the company which makes Zantac stated that the FDA reported that N-nitrosodimethylamine (NDMA) levels in ranitidine in its initial tests hardly exceed the amounts present in common foods. However, Sanofi is working closely with FDA and is also conducting its own intensive investigations to make sure that it continues to fulfil the greatest standards of quality and safety.
Source credit: https://www.cbsnews.com/news/zantac-carcinogen-cvs-pharmacy-pulls-zantac-generic-brand-over-possible-link-to-cancer-2019-09-29/
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