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Voluntary Recall of Zantac by Sanofi/FDA

Sanofi has initiated a voluntary recall of all Zantac OTC (over-the-counter) products in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®. Zantac tablets are an oral, over-the-counter product to prevent and relieve heartburn associated with acid ingestion and sour stomach. This announcement can be found on the FDA website.

On September 13, 2019, the U.S Food and Drug Administration issued a public statement alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing.

Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. products, Sanofi has made the decision to conduct the voluntary recall as the investigation continues.

Active ingredients used in Sanofi’s ranitidine products outside of the U.S. and Canada are sourced from different suppliers. Sanofi has also issued a voluntary recall in Canada. The company is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

In a separate article, Reuters has run a timeline review of Zantac - from its initiation to success to recent demise over product safety.

Reutiers -  The U.S. Food and Drug Administration and international health authorities are investigating the safety of Zantac heartburn medicine, also sold generically as ranitidine, after finding a probable cancer-causing impurity in the drug.

Ranitidine is the newest drug to be recalled, largely because of a cancer risk from impurities found in manufacturing.

The following is a timeline on Zantac:

1983

Glaxo Holdings Ltd, now a part of GlaxoSmithKline PLC, receives its first U.S. FDA approval for Zantac as a short-term treatment of a common form of ulcers. The drug was already approved in 31 different countries.

1988

Zantac becomes the world’s best selling drug and one of the first-ever drugs to top $1 billion in annual sales.

1997

Glaxo’s U.S. patent for ranitidine expires and competitors launch generic alternatives to the drug.

2004-2017

Pfizer receives FDA approval for an over-the-counter version of Zantac in the U.S. The brand later moved in various transactions to Johnson & Johnson, Boehringer Ingelheim Pharmaceuticals and Sanofi SA, which currently sells Zantac in the U.S. Other companies also launch generic over-the-counter competitors.

July 2018

European and American regulators recall blood pressure drug valsartan made by China’s Zhejiang Huahai Pharmaceuticals after finding the cancer causing impurity N-nitrosodimethylamine (NDMA) in samples of drugs containing ranitidine. The regulators have since found the impurities in a wide number of the drugs in the same class, called angiotensin II receptor blockers.

Sept. 13, 2019

U.S. and European regulators say they are reviewing the safety of ranitidine.

Sept. 18, 2019

Novartis AG’s Sandoz Unit, which makes generic drugs, says it is halting the distribution of its versions of Zantac in all markets, while Canada requests drugmakers selling ranitidine to stop distribution.

Sept. 28, 2019

Drugstore chain CVS Health Corp says it will stop selling Zantac and its own generic ranitidine products. Walmart Inc, Walgreens Boots Alliance Inc and Rite Aid Corp have also moved to remove the drugs off their shelves.

Oct 2, 2019

FDA says it has found “unacceptable levels” of N-nitrosodimethylamine (NDMA) in samples of drugs containing ranitidine in its testing.

Oct 8, 2019

GlaxoSmithKline, the original maker of the drug, recalls prescription-only Zantac medicines in all its markets as a precaution.

Oct 18, 2019

Sanofi recalls over-the-counter Zantac in the United States and Canada, a day after the UK unit of Teva Pharmaceutical, the world’s largest generic drug maker, recalled some batches of ranitidine.

 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

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