PvPI-Pharmacovigilance Programme for India is a national drug safety monitoring center for India maintained by Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. As part of routine analysis of individual case safety reports (reports of adverse drug event/reactions from a patient) originated from India, PvPI has identified and released two new drug safety alerts for the…
On 02-Jul-2020, US-FDA released a recall alert for class I medical Device– Arrow AutoCAT®2 and AC3 Optimus® IABP Series due to possible breakdown of motor connector wires. Device Use: The Arrow AutoCAT®2 and AC3 Optimus® are Intra-Aortic Balloon Pumps (IABP) are cardiac assist devices which are used for patients who are undergoing cardiac and non-cardiac…
Hydroxychloroquine is an antimalarial class of drug which is used in the treatment and prevention of acute attacks of malaria. It is also used to treat discoid or systemic lupus erythematosus, rheumatic disorders like rheumatoid arthritis, porphyria cutanea tarda and Q fever. Hydroxychloroquine acts by increasing pH within intracellular vacuoles and alter processes such as protein…
Health Canada has published new drug safety information to raise awareness to health care professionals and public about the below safety concern which recently made safety labelling changes for the product monograph. –Health Product Info Watch –June 2020. The safety topics discussed below in brief. Pulmonary edema risk with amlodipine Risks of artery dissection and…
The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts during the month of June. Restriction of domperidone use in pediatric patients less than 12 years of age Risk of oculogyric crisis associated with metoclopramide use (a reminder) Restriction of domperidone use in pediatric patients…
MedSafe- Health Authority of New Zealand government has released the below drug safety information in their latest issue-June-2020 to update public-(health care professionals & consumers) about the safe use of medicines. Tramadol use Contradicted in children & elder patients (<75 y) Oral cleft defects associated with ondansetron Tramadol use Contradicted in children &…
The national regulatory body for Indian pharmaceuticals and medical devices- Central Drugs Standard Control Organisation (CDSCO) has provided approval as part of restricted & emergency use authorization for the below two medicines considering the unmet medical need for treatment of COVID-19 infected patients- Favipiravir Tablets for mild to moderate COVID-19 infection subject to various conditions…
European medicines agency has released a new Issue (135-June-2020) for medicine updates. The drug safety updates from this issue were discussed below in brief. Fatal Drug Interactions between fluoropyrimidines and brivudine Risk of breast cancer with hormone replacement therapy Potential medication errors with Leuprorelin depot medicines Fatal Drug Interactions between fluoropyrimidines and brivudine European…
On 16-Jun-2020, US-FDA released a recall alert for class I medical Device– Ovation iX Abdominal Stent Graft Systems due to the risks of polymer leaks during implantation Device Use: This device is used in endovascular treatment for patients with an abdominal aortic or aortoiliac aneurysms (AAA). Aortic Aneurysm is a condition which occurs when the aorta…
On 11-Jun-2020, a nationwide recall of one lot of Metformin Hydrochloride ER Tablets USP, 500 mg [Lot Number: G901203] issued by Lupin Pharmaceuticals, Inc. due to the detection of N-Nitrosodimethylamine (NDMA). Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. NDMA…