Drug Safety Alerts from PvPI-Pharmacovigilance System for India

Drug Safety Alerts from PvPI-Pharmacovigilance System for India

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

benefit-risk profile for Hydroxychloroquine in the COVID-19 treatment

An unfavourable benefit-risk profile for Hydroxychloroquine in the COVID-19 treatment

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 Drug Safety Updates_June 2020

Drug Safety Updates from Health Canada-June 2020

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

Drug Safety Alerts from Malaysian Health Authority-June 2020

Drug Safety Alerts from Malaysian Health Authority (NPRA)-June 2020

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

Drug Safety Alerts from New Zealand Health Authority

Drug Safety Alerts from New Zealand Health Authority-MedSafe

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 &

COVID-19 Medicine Update

COVID-19 Medicine Update: Restricted Emergency Use authorizations (EUA) for Medications in India

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

Metformin Hydrochloride Extended-Release (ER) Tablets: Another voluntary recall

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

Voluntary Recall of Metformin Hydrochloride Extended Release Tablets

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. N‑Nitrosodimethylamine (NDMA) is classified as a probable human carcinogen (a substance with potential to cause cancer) based on results from laboratory tests. With the release of alert of NDMA presence in Metformin

Drug Safety Alert From IPC-PvPI

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

Drug Safety Alerts from Malaysian health authority

Drug Safety Alerts from Malaysian health authority

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts. Gabapentin: Risk of dysphagia Proton pump inhibitors: Risk of microscopic colitis Gabapentin: Risk of dysphagia Gabapentin is an anticonvulsant or anti epileptic drug which is used to prevent and control seizures along with other medications. It

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