America’s federal healthcare agency, the U.S. FDA has recently requested all drug manufacturers to immediately recall all over-the-counter and prescription ranitidine drugs that are commonly sold under the name Zantac from the market.
According to reliable sources, in its ongoing investigation, the FDA found that the heartburn medications observed a rise in levels of contaminants over time. In addition, when kept under higher-than-normal temperatures, the drug presented a risk to consumer’s health.
Reportedly, the contaminant, which is often categorized as NDMA (N-nitrosodimethylamine), is considered as a potential human carcinogen and the agency has been examining it since the last summer for the levels of it in ranitidine.
Speaking on the matter, Dr. Janet Woodcock, Director of Center for Drug Evaluation and Research, FDA, said that the agency didn’t notice higher levels of NDMA in several previous samples tested earlier. However, since the agency is unaware up to how long the drug will be stored, it has decided that the drug should be out of the patients’ reach unless and until its quality has been assured.
Moreover, the FDA would amplify its efforts to guarantee that impurities in other medicines do not surpass tolerable limits. This would help patients to continue their medications without any long-term effects, added Woodcock.
As per FDA order, letters are being issued to every ranitidine manufacturer, requesting them to recall products from the stores. Meanwhile, consumers are instructed to stop consuming any ranitidine liquid medications or tablets. The FDA has requested consumers to dispose these drugs properly and refrain from buying more.
In fact, due to the ongoing COVID-19 crisis, the FDA has advised customers not to return these drugs to a "drug take-back region," instead dispose them as per manufacturer’s disposal instructions given in the medication guide. Although, if the drug does not come with a guideline, then users can follow FDA's directives to ensure safe drug disposal.
Source Credit: https://edition.cnn.com/2020/04/01/health/zantac-fda-remove-from-market-bn/index.html