Medical Device Class I Recall: Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters

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

HSA Drug Safety Alert: Liver Injury associated with Fimasartan use

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

NPRA’s Drug Safety Alert: Ischaemic colitis associated with Nintedanib use

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

Voluntary Nationwide Recall of Finasteride in United States

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)

Drug Safety Alert from Malaysian Health Authority: Kounis syndrome associated with Rocuronium use

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

TGA’s Safety Advisory on Vitamin B6

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

Update on COVID-19 Treatment: A triple combination antiviral therapy shows favourable results in a Phase-2 randomised clinical trial.

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

Drug Safety Updates from Health Canada-June 2020

Drug Safety Alerts from Health Canada

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

Highlights of Remdesivir (A potential treatment for COVID-19?)

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

Medical Device Class I recall: Langston® Dual Lumen Catheters

United States FDA announced that Vascular Solutions, Inc. is recalling Langston Dual Lumen Catheter, (a class I medical device) due to risk of separation during use During angiographic studies (Medical imaging tests), this Langston Dual Lumen Catheter is utilized for the rapid delivery of contrast agents (dye materials) into the patient blood vessels. This will

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