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…
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…
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…
A new drug safety signal identified by the Uppsala Monitoring Centre (UMC), Sweden a WHO Collaborating Centre for international service and scientific research within the field of pharmacovigilance. This safety signal is identified from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO and published in the WHO Pharmaceuticals newsletter…
Hyperacusis is new drug safety signal identified for Tramadol drug by UMC (Uppsala Monitoring Center), a WHO Collaborating Centre. Hyperacusis is a rare hearing disorder which is characterized by an increased sensitivity to certain frequencies and volume ranges of sound. This disorder makes it hard to deal with everyday sounds and causes an intolerance to…
Vitamin D3 (colecalciferol) supplements are quite commonly used medications for vitamin D deficiency by all age groups especially in elderly women and young children. It also used to treat and prevent bone disorders like rickets, osteomalacia. Colecalciferol is the natural precursor of the calcium-regulating hormone calcitriol, which plays an important role in regulating calcium and…