Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for assessing and monitoring the safety of human medicines from European medicines agency (EMA) has published new significant safety information (signals) for medicines which were identified from their monthly PRAC meeting held during the period of 28 Sep-2020 to 01 Oct 2020. PRAC Recommendations for regulatory action…
Pirfenidone used in the treatment of idiopathic pulmonary fibrosis (scarring of the lung tissue). It is an inhibitor of transforming growth factor (TGF)-beta (a factor which is involved in the proliferation and differentiation of cells) and it also inhibits the TNF-Alpha. Norway health authority (Norwegian Medicines Agency) identified a new safety alert for pirfenidone from…
Norwegian Medicines Agency (health authority of Norway) published a drug safety alert of drug ineffectiveness for heparin due to interaction with andexane alpha. To foster awareness, this significant safety information is disseminated to health care professionals for early implementation of risk minimizing measures. Andexanet alpha is a recombinant modified factor Xa protein for the reversal…
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…
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…
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…
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…
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…
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…
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…