Prospective cohort of people living with HIV who started combination antiretroviral therapy (cART) regimens containing efavirenz (EFV) or dolutegravir (DTG) in three specialized HIV/AIDS care services Belo Horizonte, Brazil, the objective analyzing incidence, time to development and factors associated first adverse drug reaction (ADR). Data were collected from September 2015 October 2018 throug...

OBJECTIVES Biological DMARDs are widely used in the treatment of rheumatoid arthritis (RA) but their relationship with adverse drug reaction (ADR) is important. RA is now known to increase in incidence and prevalence with age. Our objective was to assess the incidence of severe ADR in the long term, compare safety between the different bDMARDs and identify other possible risk factors for severe...

Background: Adverse cutaneous drug reactions are unwarranted effects of modern medicine. These unfortunate events can assume any morphology from simple exanthem to full blown toxic epidermal necrolysis (TEN), and can simulate and mimic many diseases. Sometimes it is difficult to recognize the cause, but they may be due to polypharmacy or self-administration of medications. The analytical data f...

PURPOSE Abacavir is a nucleoside reverse transcriptase inhibitor indicated for human immunodeficiency virus (HIV) infection. In Japan, Ziagen® (300-mg abacavir sulfate) has been marketed since 1999. To obtain safety data on Ziagen, a mandatory postmarketing surveillance was conducted between September 1999 and September 2009. METHODS A joint survey [HIV-related Drug Surveys (HRD)] has been co...

In clinical routine, adverse drug reactions (ADR) are common, and they should be included in the differential diagnosis in all patients undergoing drug treatment. Only part of those ADR are immune-mediated hypersensitivity reactions and thus true drug allergies. Far more common are non-immune-mediated ADR, e.g. due to the pharmacological properties of the drug or to the individual predispositio...

As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. South Korea has been making continuous efforts in the field of pharmacovigilance for the last 3 decades since voluntary adverse drug reaction (ADR) reporting system was first launched in 1988. Korea joined the World Health Organization Program for Inte...

Clinical trial related injury and serious adverse events (SAE) are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensa...

BACKGROUND With the increasing popularity of Web 2.0 applications, social media has made it possible for individuals to post messages on adverse drug reactions. In such online conversations, patients discuss their symptoms, medical history, and diseases. These disorders may correspond to adverse drug reactions (ADRs) or any other medical condition. Therefore, methods must be developed to distin...

BACKGROUND Pharmacovigilance is the "science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems". Nepal joined the international pharmacovigilance programme as a full member in 2007. KIST Medical College, Lalitpur, Nepal joined the national programme as a regional centre from mid-July 2008. Currently, the patt...

PURPOSE Pharmacovigilance methods have advanced greatly during the last decades, making post-market drug assessment an essential drug evaluation component. These methods mainly rely on the use of spontaneous reporting systems and health information databases to collect expertise from huge amounts of real-world reports. The EU-ADR Web Platform was built to further facilitate accessing, monitorin...