Ranitidine not banned; a trusted and safe antacid for years
“A person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer” – USFDA
|Some facts: |
USFDA said, “Health care professionals should continue to prescribe medications when clinically appropriate even though they may have low levels of nitrosamine impurities” Neither US FDA nor the DCGI has asked for an on ranitidine Age-old medicine for treating gastric acidity
Features in WHO’s List of Essential Medicines1,2
Kolkata; February 6, 2020: A group of prominent doctors from different specialties met select media for a discussion about ranitidine, an active pharmaceutical ingredient (API) used in certain antacids.
To make aware the public at large about the developments, JB Chemicals & Pharmaceuticals Ltd., organized the meet for public awareness whereby the doctors shared their clinical experience about the molecule to educate common public.
The doctors were present to educate masses through media about ranitidine and its use in accordance with recent events.
A popular, age-old medicine used to treat gastric acidity, ranitidine was commercially introduced in 1981 and has stood up to the expectations of medical fraternity for being safe and efficacious. Ranitidine features on the World Health Organization’s List of Essential Medicines.
Contrary to the popular perception created, Ranitidine has not been banned. None of the key pharmaceutical regulators such as the US FDA, the Drug Controller General of India (DCGI) /CDSCO have asked for a ban1,. However, the recall by a few manufacturers in India was purely voluntary. The US FDA tested numerous ranitidine products and found levels of NDMA similar to levels one would be exposed to if they ate common foods like grilled or smoked meats.1
The US FDA in its recent statement issued on January 8, 2020 has said that NDMA is a known environmental contaminant found in water and certain foods. A person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.1
Dr Indranil Khan, Oncologist, AMRI Hospital, said, “USFDA, in its statement, has confirmed that ranitidine does not lead to cancer forming agents in typical stomach conditions of humans. I have been prescribing ranitidine for several years, and based on my clinical experience I can say that ranitidine is a safe drug. It is a safe and efficacious drug for hyperacidity. I myself consume it for any acidity issues.”
Prof. (Dr) Subhasish Bhattacharyya, Professor and HOD, Pediatrics CSS College of Obstetrics, Gynecology and Child Health remarked that “Contrary to common perception, ranitidine is not banned. Drug regulators have asked the state bodies to get the product tested from manufacturers to ensure patient safety. Ranitidine is prescribed for multiple conditions and is one of the safest antacids around.”
Dr N.P. Bohidar, Consultant Gastroenterologist, Narayana Health, said, “Ranitidine is not only an affordable medicine but also a trusted one over years. I have prescribed ranitidine to my patients for acid refluxes or GERD for many years with no serious side effects. The USFDA has conducted several tests and showed no additional NDMA was generated in the stomach because of ranitidine use. So we shouldn’t hesitate to prescribe ranitidine.”
Dhiman Kahali, Cardiologist, B.M. Birla
Heart and research Centre, said, “According
to the US FDA a person taking a drug that has NDMA below the acceptable limit
every day for 70 years is not expected to have an increased risk of cancer,
which answers everything. Since ranitidine is usually prescribed for a short
duration it is highly unlikely to lead to cancer. There is no need for patients
to get confused or go panic over social media messages. Rather they should
consult their doctor and follow their advice.”
 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine. Last accessed on 5th February, 2020.
 DCG(I): Govt of India, Directorate General of Health Services F No 12-03/19-DC (Safety-007) Dated 23-09-2019