Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.310
M. Dasari
{"title":"A Note on the Concept of Essential Medicines","authors":"M. Dasari","doi":"10.35248/2329-6887.21.9.310","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.310","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81005681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.315
Mohammed Aboukaoud
Background Our study is the first to utilize the OpenVigil 2.1, a universal novel web-based pharmacovigilance analysis tool to analyze real-life safety of ADHD medications with special emphasis on newer medications and psychiatric adverse events. Thorough knowledge of adverse events for each medication reveals safety signals and support treatment guidelines and clinical management of the events. Methods we analyzed adverse event cases documented in the OpenVigil 2.1 from mid-2003 until February 2020. The medical dictionary for regulatory activities (MedDRA browser English version 20.0) was used to group lower level terms with a common preferred term to be searched for in the database. The proportional reporting ratio (PRR) and the reporting odd ratio (ROR) were used to quantitate the strength of the association between reported adverse events for atomoxetine, lisdexamfetamine, amphetamine, methylphenidate (instant release, intermediate acting, long acting). Results During the period we evaluated a total of 38,412 cases reported for methylphenidate, atomoxetine, lisdexamfetamine, amphetamine. We found a significantly lower risk for depressed mood (ROR 0.026, 95%CI 0.016-0.042) and tics (ROR 0.48, 95%CI 0.30-0.76) reported for atomoxetine compared with methylphenidate. Lisdexamphetamine did not seem to decrease the risk of psychiatric events. On the contrary, lisdexamfetamine carried a six fold risk for suicidal adverse events compared with other drugs in the data and a twofold risk of suicidal adverse events and tics compared with methylphenidate. Conclusions we conclude that Atomoxetine is a good choice for patients with comorbid tics or depression or for patients who develop depressed mood on stimulants. There is a great overlap between ADHD symptoms and stimulant/non stimulant adverse events, therefore prior to medication switch, therapeutic response should be evaluated carefully. Data in the literature on lisdexamfetamine remains scarce. Owing to signals on tic disorders and suicidal adverse events, we highly recommend studying these issues further with RCT and Cohort studies.
{"title":"Safety Comparison of Atomextine and Lisdexamfetamine: Using Pharmacovigilance Database and Tools","authors":"Mohammed Aboukaoud","doi":"10.35248/2329-6887.21.9.315","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.315","url":null,"abstract":"Background Our study is the first to utilize the OpenVigil 2.1, a universal novel web-based pharmacovigilance analysis tool to analyze real-life safety of ADHD medications with special emphasis on newer medications and psychiatric adverse events. Thorough knowledge of adverse events for each medication reveals safety signals and support treatment guidelines and clinical management of the events. Methods we analyzed adverse event cases documented in the OpenVigil 2.1 from mid-2003 until February 2020. The medical dictionary for regulatory activities (MedDRA browser English version 20.0) was used to group lower level terms with a common preferred term to be searched for in the database. The proportional reporting ratio (PRR) and the reporting odd ratio (ROR) were used to quantitate the strength of the association between reported adverse events for atomoxetine, lisdexamfetamine, amphetamine, methylphenidate (instant release, intermediate acting, long acting). Results During the period we evaluated a total of 38,412 cases reported for methylphenidate, atomoxetine, lisdexamfetamine, amphetamine. We found a significantly lower risk for depressed mood (ROR 0.026, 95%CI 0.016-0.042) and tics (ROR 0.48, 95%CI 0.30-0.76) reported for atomoxetine compared with methylphenidate. Lisdexamphetamine did not seem to decrease the risk of psychiatric events. On the contrary, lisdexamfetamine carried a six fold risk for suicidal adverse events compared with other drugs in the data and a twofold risk of suicidal adverse events and tics compared with methylphenidate. Conclusions we conclude that Atomoxetine is a good choice for patients with comorbid tics or depression or for patients who develop depressed mood on stimulants. There is a great overlap between ADHD symptoms and stimulant/non stimulant adverse events, therefore prior to medication switch, therapeutic response should be evaluated carefully. Data in the literature on lisdexamfetamine remains scarce. Owing to signals on tic disorders and suicidal adverse events, we highly recommend studying these issues further with RCT and Cohort studies.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85408305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pharmacovigilance (PV) described as science & actions connecting to the identification, evaluation, awareness, & mitigation of Adverse Drug Reactions (ADRs) or associated conditions. Some serious cases of ADR contributed to the development of this discipline in the 1970s. There have been many efforts to establish such a programme in India between 1989-2004, but the system has finally begun in 2010 and is functioning successfully and achieving meaningful results. Based on the data gathered via this method, Pharmacovigilance Program of India (PvPI) contributed various data to the World Health Organization (WHO) Uppsala Monitoring Centre (UMC). They also issued some warnings to the stakeholder and made a range of suggestions to the Central Drugs Standard Control Organisation (CDSCO). CDSCO has also advised Marketing Permit Holders (MAHs) to comply with the same requirements and has introduced relevant changes to the Drugs and Cosmetics Act & Regulations. The time has arrived when Indian regulatory authorities would undertake the requisite action on the basis of data produced in our country rather than on the basis of data generated in several other countries
{"title":"An Overview of World-Wide Master Key for Drug Safety Monitoring (Pharmacovigilance) and Its Role in India","authors":"Janmejay Pant, Harneet Marwah, Ripudaman Singh, Subhajit Hazra","doi":"10.35248/2329-6887.21.9.325","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.325","url":null,"abstract":"Pharmacovigilance (PV) described as science & actions connecting to the identification, evaluation, awareness, & mitigation of Adverse Drug Reactions (ADRs) or associated conditions. Some serious cases of ADR contributed to the development of this discipline in the 1970s. There have been many efforts to establish such a programme in India between 1989-2004, but the system has finally begun in 2010 and is functioning successfully and achieving meaningful results. Based on the data gathered via this method, Pharmacovigilance Program of India (PvPI) contributed various data to the World Health Organization (WHO) Uppsala Monitoring Centre (UMC). They also issued some warnings to the stakeholder and made a range of suggestions to the Central Drugs Standard Control Organisation (CDSCO). CDSCO has also advised Marketing Permit Holders (MAHs) to comply with the same requirements and has introduced relevant changes to the Drugs and Cosmetics Act & Regulations. The time has arrived when Indian regulatory authorities would undertake the requisite action on the basis of data produced in our country rather than on the basis of data generated in several other countries","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81777681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.309
Usha Sree Kodamanchili
In recent times, oral sicknesses have gained an importance and are taken into consideration as a chief health hassle global. Oral most cancers, dental caries, and periodontal illnesses are among the most vital global oral health troubles. Even though new treatments and technology for handling them are considerable, though increasingly sufferers are actually looking for easier, gentler remedies for improving the great of lifestyles and warding off iatrogenic issues. Conventional medical structures are without difficulty on hand, less expensive and comparatively safer than different traditional medicines [1]. The time tested herbal formulations indicated in Unani fabric medica had been demonstrated effective and secure. The exploration and identification of diverse botanicals utilized in conventional and complementary remedy might also cause improvement of novel preventive or healing techniques for oral health.
{"title":"A Brief Note on Medical Management of Unani Medicine","authors":"Usha Sree Kodamanchili","doi":"10.35248/2329-6887.21.9.309","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.309","url":null,"abstract":"In recent times, oral sicknesses have gained an importance and are taken into consideration as a chief health hassle global. Oral most cancers, dental caries, and periodontal illnesses are among the most vital global oral health troubles. Even though new treatments and technology for handling them are considerable, though increasingly sufferers are actually looking for easier, gentler remedies for improving the great of lifestyles and warding off iatrogenic issues. Conventional medical structures are without difficulty on hand, less expensive and comparatively safer than different traditional medicines [1]. The time tested herbal formulations indicated in Unani fabric medica had been demonstrated effective and secure. The exploration and identification of diverse botanicals utilized in conventional and complementary remedy might also cause improvement of novel preventive or healing techniques for oral health.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83412576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.298
Saravani Udathala
Pharmacoepidemiology is a generally new science that investigates drug adequacy or poisonousness utilizing huge observational examination plans. In the previous few years, the quantity of pharmacoepidemiologic considers distributed in clinical diaries has expanded, as these investigations have investigated drugrelated inquiries that on occasion can't be replied by performing randomized preliminaries. For instance, a case-control study demonstrated that breathed in corticosteroids diminished asthmarelated passings. A randomized preliminary presumably would not have had the option to address this inquiry, as it would have been unscrupulous to deny glucocorticoid treatment to patients with asthma. Another territory of incredible general wellbeing significance that can be assessed simply by pharmacoepidemiologic examines concerns potential relationship between physician endorsed drug use and the danger of engine vehicle mishaps. Studies have indicated that methodologically stable epidemiologic examinations can give comparable outcomes to those of enormous randomized preliminaries. This article is the first of two sections on pharmacoepidemiology [1]. Four pharmacoepidemiologic study plans will be examined that investigate the relationship between a particular pharmacologic specialist and an illness of premium: accomplice considers, case-control contemplates, casehybrid examinations, and case-time-control contemplates. The subsequent article (to be distributed in the September issue of Pharmacotherapy) will give a more point by point conversation of the methodological and scientific contrasts between case-control and companion examines. Strategies for controlling for time dependent openings and frustrating utilizing the settled casecontrol study will be tended to in that article [2].
{"title":"A Note on Pharmacoepidemiology","authors":"Saravani Udathala","doi":"10.35248/2329-6887.21.9.298","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.298","url":null,"abstract":"Pharmacoepidemiology is a generally new science that investigates drug adequacy or poisonousness utilizing huge observational examination plans. In the previous few years, the quantity of pharmacoepidemiologic considers distributed in clinical diaries has expanded, as these investigations have investigated drugrelated inquiries that on occasion can't be replied by performing randomized preliminaries. For instance, a case-control study demonstrated that breathed in corticosteroids diminished asthmarelated passings. A randomized preliminary presumably would not have had the option to address this inquiry, as it would have been unscrupulous to deny glucocorticoid treatment to patients with asthma. Another territory of incredible general wellbeing significance that can be assessed simply by pharmacoepidemiologic examines concerns potential relationship between physician endorsed drug use and the danger of engine vehicle mishaps. Studies have indicated that methodologically stable epidemiologic examinations can give comparable outcomes to those of enormous randomized preliminaries. This article is the first of two sections on pharmacoepidemiology [1]. Four pharmacoepidemiologic study plans will be examined that investigate the relationship between a particular pharmacologic specialist and an illness of premium: accomplice considers, case-control contemplates, casehybrid examinations, and case-time-control contemplates. The subsequent article (to be distributed in the September issue of Pharmacotherapy) will give a more point by point conversation of the methodological and scientific contrasts between case-control and companion examines. Strategies for controlling for time dependent openings and frustrating utilizing the settled casecontrol study will be tended to in that article [2].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78928678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.324
Eric Cohen, P. Puttfarcken, C. Setze, M. Elizabeth, E. Baùsch, Cheryl Foit, M. Patwardhan
Consultation of external experts (EE) has been a standard used by biopharmaceutical project teams (PT) to help evaluate signals of drug toxicity. This process is challenging and cannot address all the complexities associated with patient safety throughout the lifecycle of a drug. AbbVie is a biopharmaceutical company that launched organspecific Internal Safety Advisory Groups (ISAG) in 2017 to address these unmet needs. Objective: To describe AbbVie’s ISAG experience from 2017 to the present, including the consultation process, breadth of consultations and methods of self-assessment. Methods: Detailed records for 7 ISAGs (hepatic, renal, ocular, cardiovascular, skin/immunology, neuropsychiatric and health literacy) were reviewed. ISAG recommendations were compared to feedback from EE and regulatory agencies as a means of comparison to industry standards. Results: The ISAGs received 41 consultations within three main categories: (a) clinical case review, (b) clinical trial management and (c) external-facing documents. The hepatic ISAG was consulted with the greatest frequency (n=24). Phase 1 (34%) and post-market (34%) were the phases with the most frequent consultations. Recommendations mirrored feedback from industry standards in 12 of 13 consults. Discussion: ISAGs provide AbbVie with broad, cross-functional expertise that is objective and readily available. Standard approaches to collection, analysis and presentation of data help guide PT and the company as a whole. ISAGs provide guidance to mitigate safety risks and communicate these risks to regulatory authorities, healthcare providers and patients. This ISAG model can be adopted within other biopharmaceutical companies and serve as a template for current or future safety advisory activities.
{"title":"Internal Safety Advisory Groups (ISAG): A Win-Win for Effective Decision-Making in Biopharmaceutical Companies","authors":"Eric Cohen, P. Puttfarcken, C. Setze, M. Elizabeth, E. Baùsch, Cheryl Foit, M. Patwardhan","doi":"10.35248/2329-6887.21.9.324","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.324","url":null,"abstract":"Consultation of external experts (EE) has been a standard used by biopharmaceutical project teams (PT) to help evaluate signals of drug toxicity. This process is challenging and cannot address all the complexities associated with patient safety throughout the lifecycle of a drug. AbbVie is a biopharmaceutical company that launched organ\u0002specific Internal Safety Advisory Groups (ISAG) in 2017 to address these unmet needs. Objective: To describe AbbVie’s ISAG experience from 2017 to the present, including the consultation process, breadth of consultations and methods of self-assessment. Methods: Detailed records for 7 ISAGs (hepatic, renal, ocular, cardiovascular, skin/immunology, neuropsychiatric and health literacy) were reviewed. ISAG recommendations were compared to feedback from EE and regulatory agencies as a means of comparison to industry standards. Results: The ISAGs received 41 consultations within three main categories: (a) clinical case review, (b) clinical trial management and (c) external-facing documents. The hepatic ISAG was consulted with the greatest frequency (n=24). Phase 1 (34%) and post-market (34%) were the phases with the most frequent consultations. Recommendations mirrored feedback from industry standards in 12 of 13 consults. Discussion: ISAGs provide AbbVie with broad, cross-functional expertise that is objective and readily available. Standard approaches to collection, analysis and presentation of data help guide PT and the company as a whole. ISAGs provide guidance to mitigate safety risks and communicate these risks to regulatory authorities, healthcare providers and patients. This ISAG model can be adopted within other biopharmaceutical companies and serve as a template for current or future safety advisory activities.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79017082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.296
A. Iqbal, Adil Rashid, H. Quraishi, Afroza Jan, Huma, Arjum, Shah
Till date four coronaviruses are found to exist i.e. human coronavirus 229E (HCoV-229E), HCoV-0C43, severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV), fourth human coronavirus, HCoV-NL63 has been reported from a seven-month-old child with bronchiolitis and conjunctival inflammation. Coronaviruses, a genus of the coronaviridae family, are enveloped viruses with large plua- strand RNA genome. The genomic RNA is 27-32 kb in size, capped and polyadenylated. After detailed and extensive research coronaviruses have been found in rats, mice, chickens, swine cattle, horses, dog, cats, rabbits, humans and can cause a wide variety of diseases including gastroenteritis and respiratory tract diseases. The most recent found SARS-CoV can lead to life threating pneumonia and is the most pathogenic human coronavirus identified so far. This fatal and highly contagious virus is likely to decide in an animal reservoir and resulted in recent epidemic in humans through zoonotic transmission.
{"title":"Corona virus and traditional approach for developing immunity through unani herbal medicine","authors":"A. Iqbal, Adil Rashid, H. Quraishi, Afroza Jan, Huma, Arjum, Shah","doi":"10.35248/2329-6887.21.9.296","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.296","url":null,"abstract":"Till date four coronaviruses are found to exist i.e. human coronavirus 229E (HCoV-229E), HCoV-0C43, severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV), fourth human coronavirus, HCoV-NL63 has been reported from a seven-month-old child with bronchiolitis and conjunctival inflammation. Coronaviruses, a genus of the coronaviridae family, are enveloped viruses with large plua- strand RNA genome. The genomic RNA is 27-32 kb in size, capped and polyadenylated. After detailed and extensive research coronaviruses have been found in rats, mice, chickens, swine cattle, horses, dog, cats, rabbits, humans and can cause a wide variety of diseases including gastroenteritis and respiratory tract diseases. The most recent found SARS-CoV can lead to life threating pneumonia and is the most pathogenic human coronavirus identified so far. This fatal and highly contagious virus is likely to decide in an animal reservoir and resulted in recent epidemic in humans through zoonotic transmission.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76642318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.334
Shreshth Khanna, A. Tayal, A. Roy
{"title":"Amoxicillin /Clavulanic Acid Induced Mixed Hepatocellular-Cholestatic Hepatic Injury- A Rare Case Report","authors":"Shreshth Khanna, A. Tayal, A. Roy","doi":"10.35248/2329-6887.21.9.334","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.334","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75385205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.21.9.316
Srujana Etela
The rapid advance of stem cell clinical trials for a broad spectrum of conditions warrants an update of the review by Trounson [1]. There has been a rapid surge in clinical trials involving stem cell therapies over the last two to three years and those trials are establishing the clinical pathways for an emergent new medicine. These early trials are showing roles for stem cells both in replacing damaged tissue as well as in providing extracellular factors that can promote endogenous cellular salvage and replenishment.
{"title":"A Note on Clinical Trials for Stem Cell Therapies","authors":"Srujana Etela","doi":"10.35248/2329-6887.21.9.316","DOIUrl":"https://doi.org/10.35248/2329-6887.21.9.316","url":null,"abstract":"The rapid advance of stem cell clinical trials for a broad spectrum of conditions warrants an update of the review by Trounson [1]. There has been a rapid surge in clinical trials involving stem cell therapies over the last two to three years and those trials are establishing the clinical pathways for an emergent new medicine. These early trials are showing roles for stem cells both in replacing damaged tissue as well as in providing extracellular factors that can promote endogenous cellular salvage and replenishment.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76076327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-01-01DOI: 10.35248/2329-6887.20.8.295
Wen-ping Shi, L. Ba, Zhi-ming Sun
Backgrounds: Dipeptidyl peptidase 4 inhibitors (DPP4is) are widely used in patients with type 2 diabetes mellitus. Recently safety report from regulatory agency suggested DPP4is may be associated with rhabdomyolysis, thus we performed a detailed analysis and evaluated the association between DPP4is and rhabdomyolysis in the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We examined the FAERS database from 2004q1 to 2017q3 (for a total of 9,906,642 reports), calculated the rates of rhabdomyolysis within the reports for DPP4is and reports for other drugs. After filtering concomitant drugs, we compared proportional reporting ratios (PRRs) among adverse events (AE) reports that listed DPP4is with and without these moderator drugs, to identify whether rhabdomyolysis is associated with the use of DPP4is alone. Results: 536 rhabdomyolysis AE reports involving DPP4is and 28462 reports involving other drugs were retrieved, the crude PRR for rhabdomyolysis associated with DPP4is was 2.06 (95%CI: 1.89-2.24). After filtering the moderator drugs, the PRR was 2.49 (95%CI: 2.08-2.98). Subanalysis showed PRR of alogliptin (11.89, 95%CI: 6.77-20.87) was higher than other gliptins and PRRs in elderly people were higher than that in working age population, regarding male or female. Conclusions: Based on this pharmacovigilance analysis, DPP4is may associated with rhabdomyolysis independently, especially alogliptin. DPP4is associated rhabdomyolysis are more likely happened on elderly people which needed to be noted in clinical practice.
{"title":"A Disproportionality Analysis of the Risk of Rhabdomyolysis Associated with DPP-4 Inhibitors in the Food and Drug Administration Adverse Event Reporting System","authors":"Wen-ping Shi, L. Ba, Zhi-ming Sun","doi":"10.35248/2329-6887.20.8.295","DOIUrl":"https://doi.org/10.35248/2329-6887.20.8.295","url":null,"abstract":"Backgrounds: Dipeptidyl peptidase 4 inhibitors (DPP4is) are widely used in patients with type 2 diabetes mellitus. Recently safety report from regulatory agency suggested DPP4is may be associated with rhabdomyolysis, thus we performed a detailed analysis and evaluated the association between DPP4is and rhabdomyolysis in the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: We examined the FAERS database from 2004q1 to 2017q3 (for a total of 9,906,642 reports), calculated the rates of rhabdomyolysis within the reports for DPP4is and reports for other drugs. After filtering concomitant drugs, we compared proportional reporting ratios (PRRs) among adverse events (AE) reports that listed DPP4is with and without these moderator drugs, to identify whether rhabdomyolysis is associated with the use of DPP4is alone. Results: 536 rhabdomyolysis AE reports involving DPP4is and 28462 reports involving other drugs were retrieved, the crude PRR for rhabdomyolysis associated with DPP4is was 2.06 (95%CI: 1.89-2.24). After filtering the moderator drugs, the PRR was 2.49 (95%CI: 2.08-2.98). Subanalysis showed PRR of alogliptin (11.89, 95%CI: 6.77-20.87) was higher than other gliptins and PRRs in elderly people were higher than that in working age population, regarding male or female. Conclusions: Based on this pharmacovigilance analysis, DPP4is may associated with rhabdomyolysis independently, especially alogliptin. DPP4is associated rhabdomyolysis are more likely happened on elderly people which needed to be noted in clinical practice.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85555502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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