No link between use of ranitidine and cancer risk: Nature study

A recent study published in scientific reports in peer reviewed journal Nature finds that there is no link between the use of ranitidine and cancer risk. 

Ranitidine is used to treat and prevent gastric ulcers. The recent study evaluated the records of 12,680 ranitidine users and 12,680 other H2RA (ranitidine-like medicines) users retrospectively. The study was conducted in South Korea on the alleged link between the use of ranitidine and cancer, which has concluded the lengthening debate on the alleged link between the use of ranitidine and the risk of cancer.

N-nitroso dimethylamine (NDMA) is a probable human carcinogen, based on laboratory studies, its effects on humans rely on observational studies. Following the detection of unacceptable levels of NDMA impurities in many ranitidine products in 2019, measures were taken to withdraw ranitidine from the market.

In September 2019, several companies including British drugmaker GlaxoSmithKline Pharma (GSK), Hyderabad based Dr Reddy's Laboratories (DRL) had withdrawn their ranitidine products from the markets following the US Food and Drug Administration (USFDA) raising concerns around presence of a cancer causing substance  in some ranitidine products.

Following this, ranitidine manufacturers in different countries (including US, EU and India) were asked by the respective drug regulators to conduct tests for determining the concentration of an impurity (N-nitrosodimethylamine or NDMA) in the ranitidine they supply.  This order came in the wake of a citizen petition filed by Valisure (a US pharmacy that chemically validates all the products it delivers to end-users). NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. FDA’s guidelines stated 0.32 parts per million or 96 nanograms of NDMA daily were acceptable.

Speaking about the research and negating the risk of the association of cancer with the use of ranitidine, one of the lead researchers, Ju-Young Shin, Sungkyunkwan University Seoul, Republic of Korea and his colleagues stated, “We found no association between ranitidine with potential NDMA impurities and risk of major individual malignancies and overall cancer.”

Ranitidine has been in existence for over four decades and has been on the WHO list of essential medicines for several years. It is commonly used in the treatment of peptic ulcer disease, gastroesophageal reflux disease. 

“The South Korean retrospective study published in nature has further affirmed the findings of previous studies concluding no association between ranitidine and cancer. The molecule has a history of 43 years and is safe to use as per available scientific evidence, I use Ranitidine as co-prescription with Dual antiPlatelet therapy for my cardiac patient along with various GI indication” said, Dr. Manoj Kumar, Senior Director & Unit Head - Cath Lab, Cardiac Sciences, Max Super Speciality Hospital, Patparganj, New Delhi  

The recent study provided no evidence of the association of NDMA impurities in ranitidine products with cancer risk, which further substantiates the US district court findings in which the Florida court dismissed almost 2,500 lawsuits alleging links between heartburn medication Zantac (Ranitidine) and cancer. The judge had said that almost 2,500 lawsuits filed in federal court by plaintiffs were based on flawed science and that the only reliable testing of the blockbuster drug undertaken showed an ‘unprovable risk of cancer’.