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 &

Drug Safety Updates from European medicines agency (EMA)-June 2020

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

Recall of Class I Medical Device- Ovation iX Abdominal Stent Graft Systems

Recall of Class I Medical Device- Ovation iX Abdominal Stent Graft Systems

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

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

Class I Medical Device Recall from the US-FDA

Class I Medical Device Recall: Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0

On 01-Jun-2020, US-FDA has released a recall alert for class I medical Device– StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License Device Use: This device is used during a deep brain stimulation (DBS) procedure which provides images

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

Medical Device Class I Recall-"HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief"

Medical Device Class I Recall-“HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief”

On 28-May-2020, US-FDA has released a recall alert for class I medical Device–HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Device Use: “HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief” are the parts of HeartWare Ventricular Assist Device (HVAD) System which help the heart in delivering blood to the rest of

EMA

Drug Safety Alerts from European medicines agency (EMA)-April 2020

EMA has released some drug safety updates in its recent Issue 133 April 2020. The safety topics discussed below based on their therapeutic areas. Meningioma risk associated with cyproterone use: Cyproterone is an antiandrogen (blocks the action of androgens, a type of sex hormone found in both men and women) and progestin medication (blocking the

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