An unacceptable benefit-risk ratio identified for a topical medicine- ‘Bufexamac’ which had been in the Over the Counter (OTC) medicine market since decades. In Brief Risks (serous skin ADRs-allergic contact dermatitis leading to hospitalization) Outweighs anticipated benefits (No proven efficacy data, reports of lack of efficacy & Insufficient studies on efficacy) Bufexamac is a cyclo-oxygenase…
PvPI-Pharmacovigilance Programme for India is a national drug safety monitoring center for India maintained by Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. PvPI is responsible for Public Pharmacovigilance activities which included collection of safety information, detection, assessment, understanding and prevention of safety concerns associated with medicinal products used by Indian citizens. As part of routine…
This concept involves determining whether any adverse drug reaction or adverse drug event is already known/already documented/already observed in subjects/patients who are under treatment with the investigational/marketed medicinal product. It determines the expeditious nature of an ICSR (Individual case safety report) by formulating the regulatory due timeline for submission to health authority (7/15 days). For…
A new safety labelling change for hydrochlorothiazide (HCTZ) drug was approved by United States Food and Drug Administration (US-FDA). Hydrochlorothiazide is loop diuretic (acts on kidneys by eliminating excess fluids) used in the treatment of high blood pressure and oedema associated with the congestive heart failure. A new safety information identified through routine pharmacovigilance (PV)…
The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts for bringing awareness to health care professionals for a better patient safety. Drug Safety Alert 1: Risk of priapism with Propofol Drug Safety Alert 2: Risk of toxic degradations of ingredients of parenteral nutrition (PN) containing…
Causality Assessment: Causality is an assessment procedure used for the determination of relationship between a drug treatment and the occurrence of an adverse drug event. When a causal relationship is identified, then adverse drug event (ADE) would be called as adverse drug reaction (ADR). The assessment of causality is a common procedure in pharmacovigilance, which…
New Measures for the Safety Use of Stimulant laxatives Stimulant laxatives are medicines used in the treatment of constipation (infrequent bowel moments). These class of medicines stimulates intestinal motility by promoting secretion of water into the bowel which in turn facilitates bowel movements. The OTC medicines available in the UK market are bisacodyl (such as…
The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts for bringing awareness to health care professionals for a better patient safety. Drug Safety Alert 1: Risk of cutaneous amyloidosis with Insulin Drug Safety Alert 2: Risk of uveitis with Topiramate Drug Safety Alert 1:…
Health Canada has published new drug safety information to raise awareness to health care professionals and public about the below safety concern which recently made safety labelling changes for the product monograph. –Health Product Info Watch –July 2020. The safety topics discussed below in brief. Risk of cerebrovascular accidents with ibrutinib Severe 6-mercaptopurine toxicity associated…
WHO-Uppsala Monitoring Center (UMC) identified a new drug safety signal-“cardiac arrhythmias-Ginkgo biloba“ from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO for international service and scientific research within the field of pharmacovigilance. In the month of July-2020, WHO-UMC has identified and released two new drug safety signals. Drug Safety…