scholarly journals Associations between osteoporosis and drug exposure: a post-marketing study of the World Health Organization pharmacovigilance database (VigiBase®)

Bone ◽  
2021 ◽  
pp. 116137
Author(s):  
Benjamin Batteux ◽  
Youssef Bennis ◽  
Sandra Bodeau ◽  
Kamel Masmoudi ◽  
Anne-Sophie Hurtel-Lemaire ◽  
...  
Keyword(s):  
World Health Organization ◽  
Drug Exposure ◽  
World Health ◽  
The World ◽  
Pharmacovigilance Database ◽  
Post Marketing ◽  
Health Organization

Impact of the “French Levothyrox crisis” on signal detection in the World Health Organization pharmacovigilance database

2018 ◽  
Vol 27 (12) ◽  
pp. 1427-1428 ◽  
Author(s):  
Charles Khouri ◽  
Bruno Revol ◽  
Marion Lepelley ◽  
Michel Mallaret ◽  
Jean-Luc Cracowski
Keyword(s):  
Signal Detection ◽  
World Health Organization ◽  
World Health ◽  
The World ◽  
Pharmacovigilance Database ◽  
Health Organization

Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision

2020 ◽  
Vol 15 (1) ◽  
pp. 4-12 ◽  
Author(s):  
Nuno Sales Craveiro ◽  
Bruno Silva Lopes ◽  
Lara Tomás ◽  
Sofia Fraga Almeida
Keyword(s):  
World Health Organization ◽  
Drug Exposure ◽  
Information Sources ◽  
Drug Withdrawal ◽  
World Health ◽  
Published Evidence ◽  
Spontaneous Reports ◽  
Drug Databases ◽  
The World ◽  
Health Organization

Introduction: Several drugs were withdrawn from the market due to safety. Objective: The aim of this study was to describe data supporting drug withdrawal from the market due to safety reasons in countries belonging to the World Health Organization. Methods: We analyzed drugs withdrawn from the market between 1990 and 2010. All medicine agencies of the countries belonging to the Program for International Drug Monitoring of the World Health Organization were contacted. To complete data, Medline, reference books and available drug databases were also searched. Information sources on which authorities based their withdrawal were categorized and the average time between the first date of exposure and withdrawal was calculated and stratified. Results: A total of 133 drugs that met the inclusion/exclusion criteria were withdrawn from the market due to safety reasons in the period reviewed (1990 - 2010). Hepatotoxicity (n=36, 27.1%), cardiac disorders (n=25, 18.8%), hypersensitivity (n=17, 12.8%) and nephrotoxicity (n=14, 9.8%) were the major reasons responsible for 69.2% of all drugs withdrawn. In most cases, Information Sources for drug withdrawal were spontaneous reports and/or case reports (n=86, 64.7%), followed by clinical trials (n=24, 18.0%). The average time between the introduction of a drug and its withdrawal due to safety reasons was 20.3 years (SD±13.8). Conclusion: According to available and published evidence, there is no gold standard to identify risks associated with drug exposure. These findings strengthen the role of different information sources within the drug safety review process.

scholarly journals Tramadol-induced hiccups: a case–noncase study in the European pharmacovigilance database

2021 ◽  
Vol 12 ◽  
pp. 204209862110212
Author(s):  
Montserrat García ◽  
Unax Lertxundi ◽  
Carmelo Aguirre
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
World Health Organization ◽  
Case Reports ◽  
Opioid Analgesic ◽  
World Health ◽  
Plain Language ◽  
The World ◽  
Pharmacovigilance Database ◽  
Health Organization

Background: Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, and even death. Hiccups can be idiopathic, organic, psychogenic, and caused by drugs. Although some case reports have suggested a possible association between tramadol and hiccups, to our knowledge, no study has analyzed this possible relationship. The aim of this study was to analyze whether a disproportionate number of cases of hiccups are reported for tramadol in the EudraVigilance database. Methods: A case–noncase study was conducted to assess the association between hiccups and tramadol, calculating reporting odds ratios (RORs) from 1 January 1995 to 11 September 2020. Cases were selected using the preferred term ‘Hiccups’. The noncases used as controls were all other adverse drug reaction reports recorded in EudraVigilance during the same period. Exposure was defined as exposure to tramadol among cases and noncases. To reduce the risk of confounding by indication, the RORs for tramadol compared with other opioids were obtained. Additionally, we performed a confirmatory analysis in the World Health Organization pharmacovigilance database, VigiBase®. Results: There were 3089 cases of hiccups in the 7,213,623 reports. Tramadol was involved in 50 cases. The ROR for tramadol exposure was 3.35 [95% confidence interval (CI) 2.53–4.43]. This association persisted when comparing tramadol with other opioids; ROR: 2.13 (95% CI 1.52–2.99). Disproportionality was also observed in VigiBase®: ROR 1.69 (95% CI 1.47–1.93). Conclusion: Our study confirms, for the first time, a possible signal for a tramadol–hiccups association. Nevertheless, observational analytical studies are needed to confirm these results Plain Language Summary Evaluation of the relationship between the tramadol and the risk of hiccups Introduction: Hiccups are sudden involuntary contractions of the diaphragm. This involuntary contraction causes the vocal cords to close very briefly, which produces the characteristic sound of a hiccup. Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, depression, disability, and in the most extreme cases, even death. Drugs are a rare cause of hiccups. Methods: This study investigated the possible association between tramadol and hiccups (an unmentioned adverse drug reaction in the Summary of Product Characteristics) in the European pharmacovigilance database (EudraVigilance) and a confirming analysis in the World Health Organization pharmacovigilance database (VigiBase). Results: Our analysis shows that hiccups is relatively more frequently reported in association with tramadol than with other medicinal products, with EudraVigilance and VigiBase confirming this association. Conclusion: Tramadol is an opioid analgesic indicated, alone or in combination with dexketoprofen or paracetamol for pain with various causes, so healthcare professionals and patients should be aware of this possible association.

Ocular safety profile of BRAF and MEK inhibitors: data from the World Health Organization Pharmacovigilance Database

Ophthalmology ◽  
2021 ◽  
Author(s):  
Camille Mettler ◽  
Dominique Monnet ◽  
Nora Kramkimel ◽  
Jean-Marc Tréluyer ◽  
Luc Mouthon ◽  
...  
Keyword(s):  
World Health Organization ◽  
Safety Profile ◽  
World Health ◽  
Mek Inhibitors ◽  
The World ◽  
Pharmacovigilance Database ◽  
Health Organization ◽  
Ocular Safety
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