How Zantac went from world's best-selling drug to being pulled from store shelves

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

Ranitidine is the newest drug in which presence of cancercausing impurities have been found. Regulators have beenrecalling some blood pressure and heart failure medicines sincelast year.

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

1988

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

1997

Glaxo's U.S. patent for ranitidine expires and competitorslaunch generic alternatives to the drug.

2004-2017

Pfizer receives FDA approval for an over-the-counterversion of Zantac in the U.S. The brand later moved in varioustransactions to Johnson & Johnson, Boehringer IngelheimPharmaceuticals and Sanofi SA, which currently sellsZantac in the U.S. Other companies also launch genericover-the-counter competitors.

July 2018

European and American regulators recall blood pressure drugvalsartan made by China's Zhejiang HuahaiPharmaceuticals afterfinding the cancer causing impurity N-nitrosodimethylamine(NDMA) in samples of drugs containing ranitidine. The regulatorshave since found the impurities in a wide number of the drugs inthe same class, called angiotensin II receptor blockers.

The European Medicines Agency said NDMA is considered a probable human carcinogen (a substance that could cause cancer) based on animal studies. NDMA is also an environmental contaminant found in water and food including meat, dairy products and vegetables, according to the U.S. Food and Drug Administration (FDA).

Sept. 13, 2019

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

Sept. 18, 2019

Novartis AG's Sandoz Unit, which makes genericdrugs, says it is halting the distribution of its versions ofZantac in all markets, while Canada requests drugmakers sellingranitidine to stop distribution.

Sept. 28, 2019

Drugstore chain CVS Health Corp says it will stopselling Zantac and its own generic ranitidine products. WalmartInc, Walgreens Boots Alliance Inc and Rite AidCorp have also moved to remove the drugs off theirshelves.

Oct 2, 2019

FDA says it has found "unacceptable levels" ofN-nitrosodimethylamine (NDMA) in samples of drugs containingranitidine in its testing.

A proposed Canada-wide class actionlaunches againstSanofi, GlaxoSmithKline, Sandoz, Pharmascience, Apotex, Pro Doc, Sanis Health, and Sivem Pharmaceuticals for not disclosing the risk of cancer associated with ranitidine.None of the allegations have been proven in court.

Oct 8, 2019

GlaxoSmithKline, the original maker of the drug, recallsprescription-only Zantac medicines in all its markets as aprecaution.

Oct 18, 2019

Sanofi recalls over-the-counter Zantac in the United Statesand Canada, a day after the UK unit of Teva Pharmaceutical, the world's largest generic drug maker, recalled somebatches of ranitidine.

Health Canada says additional prescription and over-the-counter ranitidine drugsare being recalled by Sivem Pharmaceuticals ULC and Teva Canada Limited because they may contain the NDMAabove acceptable levels.