Monitoring ranitidine's adverse effects: A pharmacovigilance study.
Journal name: World Journal of Pharmaceutical Research
Original article title: Assessment and monitoring of adverse effect of ranitidine with pharmacovigilance study
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
This page presents a generated summary with additional references; See source (below) for actual content.
Original source:
This page is merely a summary which is automatically generated hence you should visit the source to read the original article which includes the author, publication date, notes and references.
Sanika Kate, Vishal Bodke, Ruchita Badekar, Paresh Bagul, Prajval Birajdar and Pavankumar Dhoble
World Journal of Pharmaceutical Research:
(An ISO 9001:2015 Certified International Journal)
Full text available for: Assessment and monitoring of adverse effect of ranitidine with pharmacovigilance study
Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research
Doi: 10.20959/wjpr202311-28841
Copyright (license): WJPR: All rights reserved
Download the PDF file of the original publication
Summary of article contents:
Introduction
Pharmacovigilance (PV) is a critical aspect of healthcare, focusing on the identification, assessment, monitoring, and prevention of adverse drug reactions (ADRs). This study assesses the adverse effects of Ranitidine, a drug predominantly used for reducing stomach acid. Despite its therapeutic benefits, Ranitidine has been associated with potential health risks, particularly after the discovery of the carcinogenic contaminant N-nitrosodimethylamine (NDMA) in its formulations, leading to its recall and withdrawal from the market.
Importance of Pharmacovigilance
Pharmacovigilance is essential for ensuring drug safety throughout their lifecycle, from preclinical and clinical phases to post-marketing surveillance. The main objectives of pharmacovigilance include establishing a national reporting system for patient safety, evaluating the benefit-risk balance of medications, and informing healthcare stakeholders about medication safety. By systematically monitoring ADRs, healthcare professionals can better protect patients and enhance drug safety practices.
Ranitidine: History and Mechanism of Action
Ranitidine, first synthesized in the late 1970s, is an H2 receptor antagonist that significantly reduces gastric acid secretion. Initially marketed under the brand name Zantac, it was widely prescribed until concerns arose regarding its safety profile. Ranitidine functions by competitively inhibiting histamine H2 receptors in gastric parietal cells, leading to decreased acid production. Over time, it became subject to increased scrutiny, especially regarding its potential connection to various adverse events and the presence of harmful contaminants.
Adverse Effects and Health Risks
The adverse effects associated with Ranitidine intake include a range of symptoms, from gastrointestinal disturbances to neuropsychiatric effects. Notable adverse events reported include anxiety, headache, dizziness, and various cardiovascular conditions. The discovery of NDMA contamination has further exacerbated concerns, prompting regulatory bodies to remove Ranitidine from the market due to its potential carcinogenicity, particularly increasing the risk of bladder cancer with prolonged use.
Conclusion
Ranitidine's rise and fall epitomize the complexities of drug safety and the critical role of pharmacovigilance in public health. While Ranitidine was previously regarded as an effective antacid, the emergent risks related to its use, including severe adverse reactions and carcinogenic potential, underline the importance of thorough monitoring of pharmaceuticals. Ongoing vigilance in assessing the safety of medications is vital to safeguard patient health and maintain trust in healthcare practices. The landscape of drug safety continues to evolve, necessitating robust pharmacovigilance frameworks to mitigate risks associated with drug therapies.
FAQ section (important questions/answers):
What is pharmacovigilance and why is it important?
Pharmacovigilance is the science of monitoring and evaluating adverse drug reactions (ADRs) to ensure medication safety. It helps identify potential medication interactions and their impacts, thus safeguarding patients throughout the drug's development and market presence.
What is Ranitidine and what conditions does it treat?
Ranitidine is a histamine H2 receptor antagonist used primarily to reduce stomach acid. It is effective in treating conditions like Zollinger-Ellison syndrome, gastroesophageal reflux disease (GERD), and peptic ulcer disease.
What adverse effects are associated with Ranitidine?
Adverse effects from Ranitidine may include headaches, abdominal pain, confusion, and gastrointestinal disturbances. More serious effects can involve cardiovascular issues, liver problems, and allergic reactions in some patients.
Why was Ranitidine recalled from the market?
In April 2020, the FDA requested Ranitidine's market removal after detecting N-nitrosodimethylamine (NDMA), a potential carcinogen, in ranitidine products, raising safety concerns regarding cancer risk.
How does Ranitidine work in the body?
Ranitidine works by competitively inhibiting histamine H2 receptors in gastric parietal cells, leading to reduced secretion of stomach acid. This helps alleviate conditions related to excess stomach acid.
What is the Naranjo Scale used for in pharmacovigilance?
The Naranjo Scale assesses the likelihood that an adverse drug reaction is caused by a specific medication. Scores classify reactions as definite, probable, possible, or doubtful, guiding safety evaluations in clinical practice.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Monitoring ranitidine's adverse effects: A pharmacovigilance study.”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
Drugs are substances that cause a physiological effect when introduced into the body. Monitoring drugs, including prescription and over-the-counter medications like ranitidine, through pharmacovigilance helps identify any negative interactions or reactions that could arise from their use, ensuring patient safety and effective treatment outcomes.
2) Medicine:
Medicines are substances used for medical treatment. The effectiveness and safety of medicines, including ranitidine for conditions like ulcers, underscore the importance of pharmacovigilance in monitoring adverse drug reactions and promoting patient safety across different demographics and conditions.
3) Disease:
Diseases are conditions affecting normal bodily function, which can be acute or chronic. Understanding various diseases is vital for pharmacovigilance practices that assess how medications like ranitidine interact with these conditions and the possible adverse reactions they may provoke or mitigate.
4) Cancer:
Cancer is a group of diseases characterized by uncontrolled cell growth. In the context of pharmacovigilance, the potential carcinogenic effects of drugs, like ranitidine's association with NDMA contamination, underline the importance of continuous monitoring and assessment to prevent harmful effects on patients who take these medications.
5) Ulcer:
An ulcer is a sore that develops on the lining of the stomach, intestines, or other parts of the body, often caused by bacteria or medications. Ranitidine is commonly used to treat ulcers by reducing stomach acid, making pharmacovigilance essential to monitor any adverse drug reactions in patients.
6) India:
India's significance in pharmacovigilance is highlighted by its vast pharmaceutical market and the monitoring of drug safety across diverse populations. The case of ranitidine's recall due to carcinogenic risks mirrors India's efforts in aligning with global health standards to safeguard public health against harmful medications.
7) Pain:
Pain is an unpleasant sensory and emotional experience, typically signaling an underlying condition. Monitoring medications that treat pain, including their efficacy and possible side effects, is a crucial aspect of pharmacovigilance to ensure that patients receive safe and effective treatment.
8) Family:
In healthcare, family refers to the network of individuals including relatives who may play a crucial role in a patient's healthcare decisions. In pharmacovigilance, understanding family medical history can help assess the risk of adverse drug reactions for medications like ranitidine that may run in families.
9) Blood:
Blood is vital in the human body for transporting oxygen and nutrients. In pharmacovigilance, monitoring drugs that may affect blood parameters is essential, especially with medications linked to hematological adverse reactions like those associated with ranitidine use.
10) Study (Studying):
A study is a systematic investigation to establish facts or principles, often involving clinical trials. The importance of studies in pharmacovigilance lies in their role in identifying potential adverse drug reactions, as seen with ranitidine and its recall due to safety concerns.
11) Food:
Food plays a significant role in health and wellness. Certain medications can interact with food, affecting absorption and efficacy. In pharmacovigilance, it is important to assess these interactions, particularly in drugs like ranitidine, to ensure safe use in patients.
12) Pharmacology:
Pharmacology is the branch of medicine focused on drugs and their effects on living organisms. Understanding pharmacology is key in pharmacovigilance for evaluating the benefits and risks of medications like ranitidine, helping ensure patient safety throughout their use.
13) Announcement:
An announcement in healthcare can denote critical updates, such as drug recalls or safety alerts. Pharmacovigilance relies on timely announcements to inform healthcare professionals and the public about risks associated with medications like ranitidine, ensuring swift action to safeguard health.
14) Maharashtra (Maharastra, Maha-rashtra):
Maharashtra is a state in India with a significant pharmaceutical industry. Its role in pharmacovigilance includes monitoring drug safety and ensuring that medications, like ranitidine, comply with health regulations and contribute to the overall well-being of the population.
15) Substance:
A substance is any material with a defined composition. In pharmacovigilance, monitoring drug substances for quality and safety is critical, especially for those like ranitidine, which have been linked to harmful contaminants like NDMA impacting patient health.
16) Education:
Education in pharmacovigilance equips healthcare professionals with knowledge and skills to monitor drug safety effectively. Training in recognizing adverse drug reactions and understanding medication interactions is critical for optimizing patient care and ensuring safe medication practices.
17) Vomiting:
Vomiting is a common adverse effect associated with various medications, including ranitidine. In pharmacovigilance, recognizing and monitoring vomiting episodes as potential drug reactions is crucial to ensure patient safety and adjust treatment as necessary.
18) Activity:
Activity in pharmacovigilance refers to the monitoring and evaluation of drug safety and efficacy. It encompasses reporting adverse drug reactions like those observed with ranitidine, allowing for continuous improvement in patient care and medication management.
19) Nausea:
Nausea is an unpleasant sensation often linked to medications. Recognizing nausea as a potential side effect in pharmacovigilance studies, such as those for ranitidine, aids healthcare providers in evaluating patient comfort and safety when prescribing treatments.
20) Visit:
A visit, typically to a healthcare provider, is an opportunity for patients to report experiences and any adverse effects from medications. Such visits are vital in pharmacovigilance for collecting real-world data about drugs like ranitidine and their safety profiles.
21) Salt (Salty):
In pharmacology, salts are often used in drug formulation, impacting the drug's bioavailability and stability. Patients using ranitidine were advised regarding its safety concerning potential salts leading to adverse effects, emphasizing the need for thorough monitoring.
22) Burning (Burn, Burned, Burnt):
Burning sensations can be side effects of oral medications, including ranitidine. Pharmacovigilance relies on monitoring these symptoms as indicators of adverse drug reactions, enabling healthcare practitioners to make informed treatment adjustments for patient comfort.
23) Male:
The term male is significant in pharmacovigilance as drug effects can vary by sex. Understanding how medications like ranitidine may differently affect male patients is essential for tailoring safety monitoring and ensuring effective treatment outcomes.
24) Life:
Life quality, particularly in relation to health, is central to pharmacovigilance. Monitoring drugs like ranitidine for their impact on patients' quality of life helps assess overall efficacy and safety, informing healthcare decisions and treatment plans.
25) Peer review:
Peer review is a critical process in research that ensures the accuracy and reliability of scientific findings. In pharmacovigilance, peer-reviewed studies help validate findings about drug safety and efficacy, influencing regulatory decisions regarding medications like ranitidine.
26) Science (Scientific):
Science underpins pharmacovigilance, combining clinical studies, data analysis, and regulatory insights. Understanding the scientific principles of drug interactions is critical for monitoring medications like ranitidine to ensure their safe use and mitigate risks.
27) Summer:
Summer may denote a timeline associated with drug studies or regulatory reviews. Understanding seasonal variations in medication usage and side effects can enhance pharmacovigilance, prompting adjustments in monitoring processes for drugs like ranitidine.
28) Gupta:
Gupta likely relates to researchers focusing on drug safety evaluations. The contributions from scholars like Gupta play a significant role in understanding medication-related risks, developing guidelines, and ensuring public health protection in pharmacovigilance.
29) Pharmacological:
Pharmacological knowledge encompasses the study of how drugs interact with living organisms. It is foundational for pharmacovigilance, allowing healthcare practitioners to assess the effectiveness and safety of medications such as ranitidine in treating various gastrointestinal conditions.
30) Developing:
Developing new medications involves extensive research, testing, and monitoring. In pharmacovigilance, the developing stages are critical for identifying potential adverse effects early, ensuring that drugs like ranitidine are safe for public use before widespread distribution.
31) Swallowing:
Swallowing is a vital physiological process affected by medication formulations. Understanding how medications like ranitidine are ingested and absorbed informs pharmacovigilance practices that evaluate their effectiveness and safety in treating conditions like GERD.
32) Drowsiness:
Drowsiness is a notable side effect linked to many medications, including ranitidine. Recognizing and monitoring drowsiness as an adverse reaction in pharmacovigilance helps healthcare professionals make informed decisions regarding drug use in patient care.
33) Knowledge:
Knowledge gained through pharmacovigilance studies informs healthcare practices by establishing effective monitoring systems for drug safety. This understanding is particularly relevant for widely used medications like ranitidine, which require ongoing assessment for side effects.
34) Evolution:
The evolution of pharmacovigilance practices reflects advancements in understanding drug safety and patient outcomes. Continued progress is essential for monitoring established medications like ranitidine and adapting strategies to minimize adverse reactions in diverse populations.
35) Himalaya (Hima-alaya):
Similar to Himalayas, this term could denote health practices in high-altitude areas, particularly in relation to drug absorption and efficacy. Understanding these local factors is crucial in pharmacovigilance logistics for treating various conditions.
36) Pregnant:
Pregnant refers to a critical demographic in pharmacovigilance, where drug safety and effects on both mother and fetus must be vigilantly monitored. Medications like ranitidine require thorough assessment to ensure safety for use during pregnancy.
37) Quality:
Quality pertains to the efficacy and safety of medications. In pharmacovigilance, maintaining high quality in pharmaceutical products is vital, especially for drugs like ranitidine, to ensure they meet safety standards and do not cause harm to patients.
38) Falling:
Falling may relate to adverse events associated with certain medications affecting balance or coordination. Pharmacovigilance systems assess such impacts to understand the broader implications of drug safety, particularly in elderly populations utilizing drugs like ranitidine.
39) Itching:
Itching is a common side effect reported with certain medications. In pharmacovigilance, monitoring itching associated with drugs like ranitidine contributes to understanding patient reactions, supporting the need for thorough assessments of drug tolerability and safety.
40) Anxiety:
Anxiety can be both a symptom of medical conditions and a potential side effect of medications. Monitoring anxiety levels in patients taking ranitidine is vital in pharmacovigilance to identify any adverse drug reactions that may require medical intervention.
41) Vertigo:
Vertigo is a spinning sensation often linked to neurological issues or side effects of medications. In pharmacovigilance, documenting vertigo cases among users of drugs like ranitidine aids in understanding safety profiles and informing clinicians about potential risks.
42) Rajani:
Rajani may refer to a healthcare professional involved in pharmacovigilance studies. The contributions of practitioners like Rajani are essential for evaluating the safety and efficacy of medications, fostering informed decision-making based on clinical observations.
43) Sanika (Shanika):
Sanika could represent a researcher or healthcare provider actively participating in pharmacovigilance. Contributions from individuals like Sanika help deepen the understanding of drug safety and ensure that medications, like ranitidine, are appropriately monitored.
44) Pandita (Pandit):
Pandit may refer to an expert or consultant in pharmacovigilance practices. Specialists like Pandit bring invaluable expertise to the field, enhancing the overall understanding of drug safety and efficacy across varied patient populations.
45) Manas (Mano, Manash):
Manas might signify a key figure in pharmacovigilance studies, contributing to research aimed at identifying drug safety concerns. Engagement from individuals like Manas can help advance the methodologies used to monitor and report adverse drug reactions.
46) Pooja:
Pooja could denote a participant or researcher in pharmacovigilance activities. Contributions from individuals like Pooja are crucial in documenting and analyzing drug reactions, thereby ensuring medications like ranitidine are safe and effective for use.
47) Trade:
Trade in pharmaceuticals encompasses the distribution and sale of drugs. Understanding trade practices is vital in pharmacovigilance for ensuring that medications meet safety regulations and are free from harmful contaminants during distribution.
48) Worry (Worried, Worrying):
Worry in the context of pharmaceuticals often pertains to patients' concerns regarding medication safety. Effective pharmacovigilance addresses such worries by actively monitoring for adverse drug reactions and providing transparent information to alleviate patient fears.
49) Shala (Sala):
Sala might refer to a specific research or healthcare institution involved in pharmacovigilance. Institutions like Sala play an essential role in drug safety monitoring, contributing to the overall understanding of medication effects within different populations.
50) Mana:
Mana could reflect individual involvement in pharmacovigilance studies, assisting in gathering and evaluating safety data for medications like ranitidine. Such involvement is critical for ensuring comprehensive monitoring of drug effects and patient safety.
51) Amol:
Amol may represent a patient or participant in pharmacovigilance studies. Patient experiences like those of Amol can provide vital insights into drug safety, helping to inform healthcare practices and regulatory decisions centered on medications' real-world effects.
52) Hair:
Hair may relate to side effects for certain medications, such as alopecia linked to drugs like ranitidine. Monitoring these effects in pharmacovigilance helps determine the overall safety profile of medications and informs patient care decisions.
53) Milk:
Milk may refer to dietary considerations regarding medication absorption. In pharmacovigilance, understanding how substances like milk interact with drugs can help to assess their efficacy and ensure safe usage in treating conditions.
54) Sour:
Sour refers to the taste sensation that may be present in some medications. Understanding patient experiences with taste, including sourness, can augment pharmacovigilance efforts assessing overall drug tolerability and adherence.
55) Post:
Post relates to the follow-up phase after medication administration or clinical trials. Effective post-marketing surveillance in pharmacovigilance is critical for identifying long-term adverse effects of drugs like ranitidine to ensure ongoing patient safety.
56) Ter:
Ther refers to therapeutic aspects of medicine. Understanding therapeutic goals is paramount in pharmacovigilance to measure drug efficacy and safety, especially for medications intended to treat chronic conditions like those affected by ranitidine.
57) Pir:
Peer relates to the collaborative aspect of research and drug safety monitoring. Engaging in peer discussions enhances knowledge sharing and drives improvements in pharmacovigilance practices, ensuring comprehensive evaluations of medications such as ranitidine.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Monitoring ranitidine's adverse effects: A pharmacovigilance study.’. Further sources in the context of Science might help you critically compare this page with similair documents:
Adverse effect, Adverse drug reaction, World Health Organization, Drug Interaction, Acute Interstitial Nephritis, Clinical research, Pharmacological action, Patient safety, Gastroesophageal reflux disease, Adverse drug reactions (ADR), Peptic ulcer disease, Medication history, Common side effects, Local anesthetic, Pharmaceutical Education, FDA approval, Zollinger-Ellison syndrome, Naranjo scale, Pharmaceutical Education and Research, Risk of cancer, Carcinogenic risk, Benefit-risk balance, Pharmacovigilance study, Ranitidine product, N-nitroso dimethylamine, Antacid treatment, Market withdrawal, Cancerous cases, Gastrointestinal ulcer, Patient safety reporting, FDA request, Cancer-causing contaminant, N-nitroso dimethylamine (NDMA), Histamine H2 receptor, S. in Department of Medicinal Chemistry, Ph.D. in Pharmaceutics, Non-FDA-approved indications, Patient medication history, Over-the-counter (OTC) medications, Intestinal conditions, Essential medicine.