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…
The Health Science Authority (HSA) of Singapore government released a new drug safety alert for the fimasartan. Fimasartan is a non-peptide angiotensin II receptor blocker (ARB) used for the treatment of hypertension and heart failure. On 09-Sep-2010, fimasartan was initially approved in South Korea and is marketed under the brand name Kanarb by Boryung Pharmaceuticals. In…
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…
Therapeutic Goods Administration (TGA) has released a safety advisory on usage of Vitamin B6 (pyridoxine) containing medicinal products for an expected safety concern-Peripheral neuropathy. Vitamin B6 is an essential nutrient widely distributed in various foods in different forms. It is commonly present in multivitamin and mineral preparations, vitamin B complexes, and in combination with magnesium for…
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…
Remdesivir (GS-5734) is being developed by Gilead Sciences, an American biopharmaceutical company based in California with a primary therapeutic focus in antiviral medicines. Remdesivir is an antiviral drug (broad spectrum) under clinical trial investigation for the treatment of COVID-19 (coronavirus disease). Remdesivir gained public attention due to publication of some of its clinical study results…
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…
Food and Drug Administration (FDA) in the United States announced a serious safety concern on the use of hydroxychloroquine or chloroquine for the treatment of 2019 Coronavirus Disease (COVID-19) due to abnormal heart rhythms like QT prolongation and ventricular tachycardia. Currently, there are no medicines proven effective for the treatment of COVID-19. On 28‑Mar‑2020, FDA released…