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.…
On 12-May-2020, United States Food and Drug Administration (USFDA) released a recall news of medical devices (Python Embolectomy Catheters, Bard Embolectomy Catheters, and OTW Latis Cleaning Catheters) which are falling under class I category. This type of recall is most serious type of recall, as they may cause serious injuries or death. The Python Embolectomy…
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…
Finasteride is a 5α-reductase inhibitor used to treat an enlarged prostate (benign prostatic hyperplasia or BPH) or hair loss in men. It is also used to treat excessive hair growth in women and as a part of hormone therapy for transgender women. An independent testing laboratory in the US identified the minoxidil (an antihypertensive drug)…
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…
In an open label, randomised, phase 2 clinical trial, triple combination of interferon beta-1b (an injectable interferon), lopinavir–ritonavir (oral protease inhibitor) and ribavirin (oral nucleoside analogue) were shown safe and superior to monotherapy with lopinavir‑ritonavir. This triple combination shown efficacy in shortening virus shedding, alleviating symptoms, and facilitating discharge of COVID-19 patients with mild to…
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…