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Today, the US Food and Drug Administration FDA announced that it is requesting all manufacturers of ranitidine products to immediately withdraw their drugs from the market. This decision comes as a response to new FDA studies that indicate potential risks to public health stemming from N-Nitrosodimethylamine NDMA, an impurity found in some ranitidine medications commonly known by the brand name Zantac.
The FDA's Center for Drug Evaluation and Research, under Dr. Janet Woodcock's leadership, is committed to ensuring the safety of medicines Americans take. In light of growing concerns surrounding NDMA levels in these drugs, the agency has determined that prolonged exposure could result in unacceptable levels of this impurity reaching consumers and patients. As a consequence, ranitidine products will no longer be avlable for either new or existing prescriptions or over-the-counter use within the United States.
NDMA is considered a probable carcinogena substance known to potentially cause cancer. The FDA became aware of indepent lab testing that found NDMA in ranitidine in summer 2019. While low levels of this compound are commonly ingested through diet, including foods and water, sustned higher exposure could increase the risk of cancer development among s. In response to the potential health risks identified, the agency warned the public about the findings and advised considering alternative treatments in September 2019.
New FDA testing results confirm that NDMA levels rise even under normal storage conditions for ranitidine products. However, the presence of this impurity is particularly exacerbated by high temperatures, which may be experienced during distribution or when handling these medications by consumers. The analysis revealed that older products have higher levels of NDMA, with the duration since manufacture contributing to an increase in contamination.
Following today's announcement, letters will be sent to all manufacturers requesting they remove their ranitidine products from the market. Advisories are also being provided to consumers taking OTC ranitidine, who should cease using tablets or liquids currently possessed and dispose of them appropriately without purchasing more; those seeking alternative treatments for conditions that previously were managed with ranitidine may consider other approved over-the-counter medications instead. For patients on prescription ranitidine, discussions with healthcare professionals about suitable alternatives are recommed before discontinuing the medicine.
In consideration of ongoing challenges posed by COVID-19 pandemic circumstances, the FDA advises individuals agnst taking their medicines to drug take-back locations and recomms following specific disposal instructions found in medication guides or package inserts. As an alternative, consumers are encouraged to follow the agency's guidelines for home disposal methods.
The FDA will continue its commitment to ensuring the safety of medicines through ongoing reviews, surveillance, compliance efforts across all product areas, and by working with drug manufacturers to mntn safe, effective, and high-quality drug products for the American public.
To stay informed about potential risks or quality concerns related to drugs, health care professionals and patients are encouraged to report adverse reactions or quality issues through the FDA's MedWatch Adverse Event Reporting program:
Visit www.fda.govmedwatchreport.htm to submit a report online.
Alternatively, download and complete the form for submission via fax at 1-800-FDA-0178.
The Food and Drug Administration, an agency within the US Department of Health and Services, is responsible for safeguarding public health by ensuring the safety, effectiveness, and security of drugs, vaccines, and other biological products. The agency also oversees the safety and security of the nation's food supply, cosmetics, dietary supplements, electronic radiation-emitting products, and tobacco products.
For further inquiries:
Media Contact: Sarah Peddicord Phone Number: 301-796-2805
Consumer Inquiries: Call FDA at 1-888-INFO-FDA
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