Indian Journal of Pharmacology Home 

LETTER TO THE EDITOR
[Download PDF]
Year : 2021  |  Volume : 53  |  Issue : 1  |  Page : 80--81

Ranitidine: Is its injunction a warning bell?

Saubhik Dasukil1, Shiwangi Verma1, Samapika Routray1, Geetanjali Arora2, Kiran Kumar Boyina1,  
1 Department of Dentistry, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India
2 Department of Oral and Maxillofacial Surgery SGT Dental College, Gurugram, Haryana, India

Correspondence Address:
Dr. Saubhik Dasukil
All India Institute of Medical Sciences, LIG 1/11, Nandi Ghosh Enclave, Sijua, Patrapara, Bhubaneswar - 751 019, Odisha
India




How to cite this article:
Dasukil S, Verma S, Routray S, Arora G, Boyina KK. Ranitidine: Is its injunction a warning bell?.Indian J Pharmacol 2021;53:80-81


How to cite this URL:
Dasukil S, Verma S, Routray S, Arora G, Boyina KK. Ranitidine: Is its injunction a warning bell?. Indian J Pharmacol [serial online] 2021 [cited 2021 Sep 21 ];53:80-81
Available from: https://www.ijp-online.com/text.asp?2021/53/1/80/315089


Full Text



Sir,

Ranitidine is an H2 blocker popularly available as an over-the-counter (OTC) and prescription drug in India, with 1.3 billion population. In April 2020, the Food and Drug Administration (FDA) recalled all ranitidine products (injectable and oral) after the revelation of low-level N-nitrosodimethylamine (NDMA) presence.[1] N-Nitrosamines have marked as human carcinogens, associated with cancers of stomach, esophagus, nasopharynx, and bladder.[2] This drug evolution started with Glaxo holdings described in the flowchart until April 2020 [Figure 1]. The most popular OTC version of ranitidine, well-known as Zantac, used for relieving and preventing heartburn for decades. The prescription version is permitted to treat gastroesophageal reflux disease (GERD), gastric ulcers, and duodenal ulcers and prevent stress ulcers.[3] It inhibits both gastric acid secretion and basal gastric secretion, induced by secretagogues such as histamine and pentagastrin.{Figure 1}

New testing confirmed that a combination of heat and time might be the culprit for NDMA contamination. The longer the exposure, the higher the contamination level.[1] The drug is banned based on risk versus benefit ratio evaluated after postmarketing surveillance and adverse drug reaction (ADR) reporting system. The question now arises: Why the delay in reporting of contamination by the carcinogen NDMA? Was it a result of the crippled pharmacovigilance protocol? How do we strengthen the system to curb further damage?

The Indian public is infamous for their tendency toward self-medication, stereotypically not supervised by physicians. Therefore, they miss the critical step of getting warned about ADR reporting, which implicates their lack of awareness and attitude toward safety issues associated with any medications. In the same line, the general population is unaware of the severe side effects of ranitidine, even after the intervention done by the FDA. Although each country has its procedure to ban the availability of the drug, the Indian market tends to continue selling until the stock persists due to authorized lack of supervision. Considering countries' concern with the use, availability, and distribution of the banned drug, it is an utmost challenge to make the masses aware of the same, especially in India's rural pockets.

Consensus data reveal that GERD affects >10% of the Indian population attributable to dietary habits such as a plethora of spices and nonvegetarian food.[4] Antacids, histamine H2 receptor blockers (H2RAs), and proton pump inhibitors (PPI) are frequently used drugs for relieving symptoms. Popular heartburn drug, Zantac (ranitidine) is imposed to be withdrawn from the market, so the next alternatives will be cimetidine, famotidine, pantoprazole, rabeprazole, esomeprazole, lansoprazole, omeprazole, etc., for OTC antacid drugs. Cimetidine and famotidine had already encountered an issue with the shortage of raw materials in Canada and other countries. Whereas the PPI class of drugs directly blocks the stomach's acid secretion, which may increase the risk of gastric infection or diminish the absorption of magnesium and vitamin B12. However, the statement advised, “Before switching to another agent, review if patients still require treatment or could be stepped down to an antacid or alginate.”[5]

Hence, finally, is this recall an awakening for us to support the ban of OTC drugs, which has been under the line of fire for safeguarding the Indian community since decades?

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1Food and Drug Administration (US) Requests Removal of All Ranitidine Products (Zantac) from the Market .US: Food and Drug Administration ; 2020.
2Mirvish SS. Role of N-nitroso compounds (NOC) and N-nitrosationin etiology of gastric, esophageal, nasopharyngeal and bladder cancer and contribution to cancer of known exposures to NOC. Cancer Lett 1995;93:17-48.
3Boehringer Ingelheim Pharmaceuticals Inc (US). Zantac® launches innovative integrated marketing campaign to educate consumers on heartburn relief. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc;2013.
4Bhatia SJ, Makharia GK, Abraham P, Bhat N, Kumar A, Reddy DN, et al. Indian consensus on gastroesophageal reflux disease in adults: A position statement of the Indian Society of Gastroenterology. Indian J Gastroenterol 2019;38:411-40.
5Mahase E. Ranitidine: Doctors should switch patients to alternative, says health department. BMJ 2019;367:l6087.