“Benadryl Challenge” in Social media: USFDA warns about serious safety concerns associated with diphenhydramine overdose

“Benadryl Challenge” in Social media: USFDA warns about serious safety concerns associated with diphenhydramine overdose

Drug Safety Alert, Global Safety Alerts, Medicinal Product Updates, US-FDA, USFDA-United States of America, Voluntary ADR reporting, , ,

U.S. Food and Drug Administration (FDA) alerted health care professionals and general public through recent drug safety communication which concerns about serious risks (heart problems, seizures, coma, and sometimes fatal outcomes) due to allergy medicine-diphenhydramine administration higher than the recommended dosage and overdose occurrences due to ‘Benadryl Challenge’ circulating in Social media- TikTok. Diphenhydramine is…

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USFDA issues 'Boxed Warning' for Benzodiazepine class of medicines

Boxed Warning for Benzodiazepine class of medicines: US-FDA Drug Safety Communication

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reporting, ,

U.S. Food and Drug Administration (FDA) released a drug safety communication to update health care professionals and consumers on the significant safety information pertaining to the benzodiazepines class of medications which included “serious risks of drug abuse, drug addiction, physical dependence, and drug withdrawal reactions” which require a boxed warning to be included in all…

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An Unfavourable benefit-risk profile for Bufexamac: Safety Advisory from TGA

An Unfavourable benefit-risk profile for Bufexamac: Safety Advisory from TGA

Drug Withdrawal, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, TGA-Australia, Voluntary ADR reporting, , ,

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…

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Drug Safety Alerts for Pramipexole & Fluvoxamine from PvPI (Pharmacovigilance Programme of India)

Drug Safety Alerts for Pramipexole & Fluvoxamine from PvPI (Pharmacovigilance Programme of India)

Drug Safety Alert, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, PvPI-India, , , , , ,

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…

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Assessing Labelling, Listedness, Expectedness in Pharmacovigilance

Assessing Labelling, Listedness, Expectedness in Pharmacovigilance: Differences & Methodology used in assessment

Aggregate report writing, Individual Case Safety Reports, Pharmacovigilance, , ,

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…

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Hydrochlorothiazide: Drug Safety Update (Label Changes) from USFDA

Hydrochlorothiazide: Drug Safety Update (Label Changes) from USFDA

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, US-FDA, USFDA-United States of America, ,

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)…

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Drug Safety Alerts from NPRA-Malaysian Health Authority-August 2020

Drug Safety Alerts from NPRA-Malaysian Health Authority

Drug Safety Alert, Global Safety Alerts, Medicinal Product Updates, NPRA-Malaysia, Voluntary ADR reporting, ,

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…

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Class I Medical Device Recall: Medfusion 3500 and 4000 Syringe Pumps

Medfusion 3500 and 4000 Syringe Pumps: Class I Medical Device Recall by US-FDA

Global Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of America, ,

On 24-Aug-2020, US-FDA has released a recall alert for class I medical Device- Medfusion 3500 and 4000 Syringe Pumps due to risk of medication delivery error. Device Use: This is used in the delivery of following products into the patient’s body in a controlled manner. Blood Blood products Prescribed medications Other fluids Syringe pumps which…

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Causality Assessment in Pharmacovigilance

Causality Assessment in Pharmacovigilance: Concept & Methods

Aggregate report writing, Individual Case Safety Reports, Pharmacovigilance, , ,

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…

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Stimulant Laxatives-Safety Update from UK Health Authority- MHRA

Stimulant Laxatives-New Safety Measures by MHRA-UK

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, MHRA-United Kingdom, Pharmacovigilance, Voluntary ADR reporting, , ,

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…

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