Adverse drug reactions (ADRs) are an important clinical problem and contribute significantly to mortality and morbidity. Scant data on the safety of drug use in children are usually available at the time of marketing authorization, due to the limited number of trials performed in the paediatric population. Few studies monitored the incidence of ADRs in Italian hospitalized children, that cannot...

BACKGROUND Adverse drug reactions (ADRs) are a well-recognized public health problem and a major cause of death and hospitalization in developed countries. The safety of a new drug cannot be established until it has been on the market for several years. Keeping drug reactions under surveillance through pharmacovigilance systems is indispensable. However, underreporting is a major issue that und...

Background : Pharmacovigilance systems are crucial for monitoring, ensuring the safe use of medications, and reducing frequency adverse drug reactions (ADRs). They also raise awareness importance reporting ADRs to healthcare systems. Aim Explore hampered perspective held by Duhok pharmacists, particularly those employed in hospitals private pharmacy sectors, about pharmacovigilance ADR reportin...

An article in the National Post on suicidal effects associated with varenicline (Champix) highlights deficiencies in the Canadian spontaneous reporting system (SRS) for adverse drug reactions (ADRs). The issues of under-reporting, poor quality information, duplication of reports and lack of a population denominator of drug use are discussed. Canada's SRS is deficient. There are immediate and me...

OBJECTIVE To assess the pharmacovigilance awareness among the healthcare professionals in a teaching hospital in Northern India. MATERIAL AND METHODS A questionnaire which was suitable for assessing the basic Knowledge, Attitude and the Practice (KAP) of pharmacovigilance was designed and distributed among 100 doctors of the Punjab Institute of Medical Sciences (PIMS) Hospital, Jalandhar, Pun...

BACKGROUND Despite surveillance efforts, unexpected and serious adverse drug reactions (ADRs) repeatedly occur after marketing. The aim of this article is to analyse ADRs reported by available ADR signal detection approaches and to explore which information about new and unexpected ADRs these approaches have detected. METHODS We selected three therapeutic cases for the review: antibiotics for...

BACKGROUND The safety of medicines used in children is of considerable public interest, yet available data to monitor the safety of medicines in children is limited. AIMS To raise awareness and stimulate reporting of adverse drug reactions (ADRs) in children in the Trent region. METHODS A pilot Paediatric Regional Monitoring Centre (PRMC) has been established in the Trent region. The scheme...

Background & aims The Medicines and Healthcare Regulatory Authority (MHRA) in the UK runs a national spontaneous reporting system (Yellow Card Scheme) to collect ‘suspected’ Adverse Drug Reactions (ADRs) for all medicines. To increase the data for paediatric medicines, current MHRA advice is to report all suspected ADRs in paediatric patients. Yellow Cards submitted between 2000 and 2009 were a...

BACKGROUND Antihistamines are used for the treatment of allergic rhinitis, allergic conjunctivitis, chronic spontaneous urticaria and atopic eczema. OBJECTIVE To study the reports of adverse drug reactions (ADRs) in children using antihistamines to provide prescribers with an overview of the possible toxicity. DESIGN We studied ADRs in children reported to the Netherlands Pharmacovigilance ...

A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions (ADRs). The aim of this study is to further explore the differences between men and women with regard to reported ADRs, particularly those associated with psychotropic drugs. We used spontaneous reports of suspected ADRs collected by Midi-Pyrénées (France)...