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Heartburn Medication Zantac Contains Cancer Causing Chemical

FDA Requests Removal of All Ranitidine Products (Zantac) from the Market

FDA Advises Consumers, Patients and Health Care Professionals After New FDA Studies Show Risk to Public Health

Lab tests found Zantac contained levels of a cancer causing chemical NDMA 3100 times greater than the FDA’s accepted safe limit. The popular heart burn medication has now been recalled.

The FDA found NDMA in ranitidine, best known by the brand name Zantac, and warned the public in September 2019 of the potential risks and to consider alternative OTC and prescription treatments.  At the time, the agency did not have enough scientific evidence to recommend whether individuals should continue or stop taking ranitidine.  With today’s announcement, the FDA is sending letters to all manufacturers of ranitidine, best known by the brand name Zantac, requesting they withdraw their products from the market.  The FDA is also advising consumers taking OTC ranitidine, to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products for heartburn.  Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine, that do not carry the same risks from NDMA.

If you took Zantac at least twice a week for a 6 month period or more, and you developed one of the cancers listed below, we think you may have a case.

Get a free case evaluation if you or a loved one took Zantac and developed one of the following cancers:  

  • Leukemia
  • Bladder Cancer
  • Esophageal Cancer
  • Kidney Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Stomach Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Intestinal Cancer
  • Liver Cancer
  • Ovarian Cancer
  • Uterine Cancer

Zantac recall

Helpful Links

Your Heartburn Drug has been Recalled.  Now What? (1-19-2020)

https://www.nbcnews.com/health/health-news/your-heartburn-drug-has-been-recalled-now-what-n1117696

Lab Finds NDMA in Zantac can Develop During Storage (1-3-2020)

https://www.fiercepharma.com/manufacturing/lab-finds-ndma-zantac-can-develop-during-storage-bloomberg

Carcinogen in Heartburn Drug May Build in Storage, Lab Finds (1-2-2020)

https://www.bloomberg.com/news/articles/2020-01-02/carcinogen-in-heartburn-drug-may-build-during-storage-lab-finds

Questions and Answers: NDMA Impurities in Ranitidine (commonly known as Zantac) (10-11-2019)

https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac

Zantac Recalled Urgently Across World Over Cancer-Linked Chemical Fears (10-9-2019)

https://www.independent.co.uk/news/business/news/zantac-cancer-ranitidine-recall-heartburn-drug-prescription-gsk-health-a9148401.html

GSK Joins Other Drugmakers Recalling Zantac Products (10-9-2019)

https://www.fiercepharma.com/manufacturing/gsk-joins-other-drugmakers-recalling-zantac-products

Potentially Dangerous Chemical Found in Popular Heartburn Pill Zantac (10-8-2019)

https://www.cbsnews.com/news/zantac-ndma-levels-potentially-dangerous-chemical-zantac-ranitidine-heartburn-pills-2019-10-08/

Zantac in Global Recall Over ‘Unacceptable’ Levels of Potential Carcinogen (10-8-2019)

https://www.theguardian.com/business/2019/oct/09/zantac-in-global-recall-over-unacceptable-levels-of-potential-carcinogen

FDA Warns Pregnant Mothers of Heartburn Medication Zantac (10-3-2019)

https://www.wfla.com/8-on-your-side/recall-alerts/fda-warns-pregnant-mothers-of-heartburn-medication-zantac/

Does Zantac Break Down Into a Carcinogen? (10-3-2019)

https://www.medpagetoday.com/special-reports/exclusives/82550

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) (10-2-2019)

https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine

FDA Now Says Impurity Level in Zantac and Other Antacids is Too High (10-2-2019)

https://www.fiercepharma.com/manufacturing/fda-now-says-impurity-level-zantac-and-other-antacids-too-high

FDA Challenges Testing Used by Lab that Found a Carcinogen in Zantac and Other Heartburn Meds (10-2-2019)

https://www.statnews.com/pharmalot/2019/10/02/fda-heartburn-carcinogen-zantac-testing/

Zantac’s Original Maker Halts Shipping on Carcinogen Concern (9-25-2019)

https://www.bloomberg.com/news/articles/2019-09-25/zantac-s-original-maker-halts-distribution-on-carcinogen-concern

Boehringer Ingelheim, Sanofi Targeted in Class-Action Suit over Zantac (9-16-2019)

https://dailyvoiceplus.com/fairfield/fairfield-business-journal/courts/boehringer-ingelheim-sanofi-targeted-in-class-action-suit-over-zantac/775606/

 

 

Zantac Heartburn Drug May Contain Carcinogen: FDA (9-13-2019)

https://www.webmd.com/heartburn-gerd/news/20190913/zantac-heartburn-drug-may-contain-carcinogen#1

Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines (9-13-2019)

https://www.fda.gov/safety/medical-product-safety-information/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines

Class Action Complaint (9-13-2019)

https://www.classaction.org/media/garza-et-al-v-sanofi-aventis-us-llc-et-al.pdf

Statement Alerting Patients and Health Care Professionals of NDMA Found in Samples of Ranitidine (9-13-2019)

https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine

Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA) (1-2014)

https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf

Zantac Prescribing Information (4-2009)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018703s068,019675s035,020251s019lbl.pdf

J&J, Pfizer Unload Zantac (10-12-2006)

https://www.thestreet.com/story/10314761/1/jj-pfizer-unload-zantac.html

Zantac Prescribing Information (10-2004)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018703s065,019675s031,020251s016lbl.pdf

The Long Shadow of Patent Expiration: Generic Entry and RX to OTC Switches (1-17-2002)

http://www.margaretkyle.net/Rx%20to%20OTC%20paper.pdf

Zantac EFFERdose FDA Approval Letter (10/29/1999)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantacefferdose_approv.pdf

FDA Drug Approval Package (10-29-1999)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection.cfm

Center for Drug Evaluation and Research (20-745) (2-19-1998)

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020745_S000_ZANTAC%2075%20EFFERDOSE%20EFFEREVESENT%20TABLETS_ADMINCORRES.PDF

Glaxo Makes Sober Forecast as Rivals of Zantac Increase (3-7-1997)

https://www.wsj.com/articles/SB857678554279459500

Zantac Will be Sold Over the Counter (12-20-1995)

https://www.spokesman.com/stories/1995/dec/20/zantac-will-be-sold-over-the-counter/

FDA Approved Drugs Products (12-19-1995)

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020520

Glaxo’s Search:  Son of Zantac (10-11-1989)

https://www.nytimes.com/1989/10/11/business/glaxo-s-search-son-of-zantac.html

Generic Zantac 300 Availability

https://www.drugs.com/availability/generic-zantac-300.html

Generic Zantac 150 Availability

https://www.drugs.com/availability/generic-zantac-150.html

FDA Approved Drug Products

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021698