IPSIndian Journal of Pharmacology
Home  IPS  Feedback Subscribe Top cited articles Login 
Users Online : 1021 
Small font sizeDefault font sizeIncrease font size
Navigate Here
  Search
 
  
Resource Links
   Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
   Article in PDF (815 KB)
   Citation Manager
   Access Statistics
   Reader Comments
   Email Alert *
   Add to My List *
* Registration required (free)

 
In This Article
   References
   Article Figures

 Article Access Statistics
    Viewed156    
    Printed4    
    Emailed0    
    PDF Downloaded10    
    Comments [Add]    

Recommend this journal

 


 
 Table of Contents    
LETTER TO THE EDITOR
Year : 2021  |  Volume : 53  |  Issue : 1  |  Page : 80-81
 

Ranitidine: Is its injunction a warning bell?


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

Date of Submission22-Sep-2020
Date of Decision05-Jan-2021
Date of Acceptance17-Mar-2021
Date of Web Publication28-Apr-2021

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

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijp.ijp_929_20

Rights and Permissions



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;53:80-1

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 May 15];53:80-1. Available from: https://www.ijp-online.com/text.asp?2021/53/1/80/315089




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: Inception and evolution of ranitidine from its first approval till date

Click here to view


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 Top

1.
Food and Drug Administration (US) Requests Removal of All Ranitidine Products (Zantac) from the Market .US: Food and Drug Administration ; 2020.  Back to cited text no. 1
    
2.
Mirvish 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.  Back to cited text no. 2
    
3.
Boehringer Ingelheim Pharmaceuticals Inc (US). Zantac® launches innovative integrated marketing campaign to educate consumers on heartburn relief. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc;2013.  Back to cited text no. 3
    
4.
Bhatia 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.  Back to cited text no. 4
    
5.
Mahase E. Ranitidine: Doctors should switch patients to alternative, says health department. BMJ 2019;367:l6087.  Back to cited text no. 5
    


    Figures

  [Figure 1]



 

Top
Print this article  Email this article
 

    

Site Map | Home | Contact Us | Feedback | Copyright and Disclaimer
Online since 20th July '04
Published by Wolters Kluwer - Medknow