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

Drug safety updates from Ireland health authority (HPRA)-May 2020

Below Safety Updates for medicinal products were released for the month of May-2020 by Ireland Health Authority-Health Products Regulatory Agency (HPRA)   A confirmed “Negative Benefit-Risk Profile” for Picato (ingenol mebutate) Risk of abnormal and aggressive behaviors with Levetiracetam use Restricted use of Cyproterone acetate due to risk of meningioma Restricted use of thyroid drugs

Voluntary reporting of medicine side effects from Public

Spontaneous reporting of adverse effects/reactions/experiences of medicinal products is quite essential for generating the safety information of a medicine (for both new & well established medicinal products). Voluntary side effects reporting is a significant source for real world drug safety experience. A transparent benefit risk profile for a pharmaceutical medicinal product can be achieved through

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