A new drug safety alert (Hydroxychloroquine-Moth Ulceration) released by the Pharmacovigilance Programme of India (PvPI) from Indian Pharmacopoeia commission (IPC) Mouth Ulceration associated with Hydroxychloroquine use Hydroxychloroquine is an antimalarial class of drug which is used in the treatment and prevention of acute attacks of malaria. It also used to treat discoid or systemic lupus…
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…
Photosensitivity reaction, a new drug safety signal for midostaurin identified based on the safety evidence from French pharmacovigilance database, the Base Nationale de Pharmacovigilance (BNPV) and from the global drug safety database, VigiBase which is maintained by WHO-UMC (Uppsala Monitoring Center). Midostaurin is a multiple tyrosine kinase inhibitor (including FLT3 and KIT kinases) which inhibits mast…
A new drug safety signal was triggered from the WHO’s global drug safety database for pharmacovigilance activities. This signal was identified by the UMC (Uppsala Monitoring Center), a WHO Collaborating Centre for international service and scientific research within the field of pharmacovigilance. Agomelatine Agomelatine is an atypical antidepressant medication used to treat major depressive disorder.…
The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released a new drug safety alert for nintedanib. Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) indicated for the treatment of idiopathic pulmonary fibrosis in adults and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung…
The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released a new drug safety alert for rocuronium. Rocuronium is an amino steroid non-depolarizing neuromuscular blocker or muscle relaxant which is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation, provide skeletal muscle relaxation during surgery and facilitating mechanical ventilation in…
Health Canada has released two new drug safety alerts to raise awareness to health care professionals and public about the two safety concerns which recently made safety labelling changes for the respective product monographs. –Health Product Info Watch – April 2020. Below are the two safety concerns discussed in brief. Interstitial lung disease risk associated…
EMA has released some drug safety updates in its recent Issue 133 April 2020. The safety topics discussed below based on their therapeutic areas. Meningioma risk associated with cyproterone use: Cyproterone is an antiandrogen (blocks the action of androgens, a type of sex hormone found in both men and women) and progestin medication (blocking the…
The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts. Drug Safety Alert 1: Risk of anaphylaxis associated with Guselkumab use Drug Safety Alert 2: Kounis syndrome associated with Intravenous iron-containing products Drug Safety Alert 3: Reports of cytomegalovirus (CMV) infection or reactivation with Nivolumab use…
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…