What is Ranitidine?
Ranitidine is a type of drug called histamine H2-receptor antagonist. It works by decreasing the amount of acid produced in the stomach and is commonly used to treat conditions like heartburn, acid indigestion, sour stomach, and gastroesophageal reflux disease (GERD). Ranitidine is available both over-the-counter and by prescription under various brand names like Zantac.
Recent recalls of Ranitidine products
In September 2019, the US Food and Drug Administration (FDA) found that some ranitidine products contain low levels of a contaminant called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a chemical by-product that forms during certain industrial and manufacturing processes, including the production of ranitidine. Following this discovery by the FDA, numerous ranitidine products were recalled by manufacturers both in the US and other countries like Canada, Australia, and the European Union.
Health risks associated with NDMA
NDMA is not intended to be present in Ranitidine or any other drug products. The International Agency for Research on Cancer has classified NDMA as a probable human carcinogen based on lab tests. Exposure to high levels of NDMA may cause liver damage or increase risk of cancers like stomach, colorectal, lung or bladder cancers with long term exposure. However, it is still unclear as to what low levels of NDMA exposure from ranitidine could potentially mean in terms of health risks. Most regulatory agencies advise that risk depends on dosage and duration of exposure and recommend consulting a doctor about alternative treatment options.
Concerns over NDMA levels in various ranitidine products
Following the initial findings in September 2019, further tests by regulatory agencies and researchers found varying levels of NDMA contamination in different ranitidine products on the market. In some cases, levels detected were higher than the acceptable daily intake limits defined by various agencies. For example, Valisure, an online pharmacy tested over 250 lots of ranitidine from multiple manufacturers and found that 81% of samples contained some level of NDMA. Some batches showed levels exceeding the FDA's daily intake limit of 96 nanograms. This prompted widespread recalls of both prescription and over-the-counter forms of ranitidine manufactured by major companies.
Changes in guidance issued by health agencies
Due to the unclear long term health implications and inconsistencies seen across different ranitidine batches, health agencies adopted a precautionary approach and provided new guidance. In April 2020, the FDA requested all ranitidine manufacturers to withdraw their products from the US market. They also advised patients taking prescription forms of ranitidine to consider other treatment options due to cancer risks. Similarly, in Canada, Health Canada reevaluated the benefit-risk assessment for ranitidine and advised suspension of product licenses. However, other regulatory bodies are still investigating potential causes and extent of NDMA contamination in ranitidine.
Alternatives to ranitidine for managing acid reflux and heartburn
While ranitidine was a commonly prescribed drug due to its effectiveness and safety profile established over years of use, the recalls may require a shift to alternative treatment options. For cases of occasional heartburn, over-the-counter antacids containing calcium, magnesium or aluminum compounds can help neutralize stomach acid. For frequent symptoms or those not responding to antacids, H2 blockers like famotidine (Pepcid) or nizatidine (Axid) are alternatives to ranitidine that work similarly but have not been associated with NDMA risks so far. Proton pump inhibitors like omeprazole (Prilosec), pantoprazole (Protonix) or esomeprazole (Nexium) can also provide long-lasting acid suppression. Lifestyle changes like weight loss, elevating the head while sleeping and dietary modifications may complement drug-based approaches depending on the underlying cause. Patients are advised to consult their doctor about suitable ranitidine replacement options based on individual conditions and preferences.
Uncertainties remain over causes and implications
While short term suspension and withdrawal of ranitidine appears prudent as per regulatory agencies, further research is ongoing to establish root causes, evaluate contamination mechanisms and clarify health implications associated with NDMA contamination, especially at low levels of chronic exposure. Studies indicate possible factors like manufacturing impurities or degradation during storage. The exact levels that could potentially be of concern also need better quantification. Post market surveillance may provide additional useful insight. Regulators continue working with companies and independent researchers to address unresolved issues and determine if ranitidine products with very low NDMA levels should be allowed back in the market with additional control measures.
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Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. With an MBA in E-commerce, she has an expertise in SEO-optimized content that resonates with industry professionals. (https://www.linkedin.com/in/ravina-pandya-1a3984191)
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