Oligohydramnios associated with NSAID use in Pregnancy-Safety Communication from USFDA

Oligohydramnios associated with NSAID use in Pregnancy-Safety Communication from USFDA

United States Food and Drug Administration (US-FDA) has issued a safety communication on the potential risk of oligohydramnios in pregnant women when exposed to medicinal products that belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) during pregnancy of 20 weeks gestational age. FDA issued this communication to alert health care professionals and consumers for

Dimethyl fumarate induced Alopecia areata: Drug Safety Alert from Netherlands Pharmacovigilance Center (LAREB)

A new drug safety signal “Dimethyl fumarate included Alopecia areata” identified by Netherlands Pharmacovigilance center, Lareb Dimethyl fumarate is an anti-inflammatory and immunomodulatory agent which is used in the treatment of relapsing multiple sclerosis and plaque psoriasis. Alopecia areata is an autoimmune disorder which involves loss of hair follicle with one or more circular bald

Potential medication error and unintentional overdose associated with methotrexate use

Methotrexate is an immunosuppressant medication used in the treatment of autoimmune diseases and some type of cancers. It acts by competitively inhibiting the dihydrofolate reductase (DHFR), a key enzyme involved in the synthesis of DNA, RNA, thymidylates, and proteins. Different regulatory bodies issued alerts on the safety concerns of medication errors and fatal overdose occurrences

Tocilizumab and Cutaneous Vasculitis: A Drug Safety Signal from WHO-UMC

This is the third drug safety signal – “Cutaneous Vasculitis association with Tocilizumab use” detected from the VigiBase by the UMC (Uppsala Monitoring Center). UMC is a WHO Collaborating Centre present in Sweden for international service and scientific research within the field of pharmacovigilance. Tocilizumab is an immunosuppressive agent and a biologic medication (fully human

Alectinib – Rhabdomyolysis: A Drug Safety Signal from WHO-UMC’s VigiBase Database

A new drug safety signal- “Rhabdomyolysis association with Alectinib” identified by the UMC (Uppsala Monitoring Center), from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO. UMC is a WHO Collaborating Centre present in in Sweden for international service and scientific research within the field of pharmacovigilance. Alectinib is an

Drug Safety Signal from WHO-UMC: Acyclovir or valaciclovir – Acute generalised exanthematous pustulosis

A new drug safety signal “Acyclovir or valaciclovir – Acute generalised exanthematous pustulosis”, identified by the UMC (Uppsala Monitoring Center), a WHO Collaborating Centre for international service and scientific research within the field of pharmacovigilance. This drug safety signal is identified from the VigiBase, a global drug safety database maintained by UMC on behalf of

“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

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

USFDA issues 'Boxed Warning' for Benzodiazepine class of medicines

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

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

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

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

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

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

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