Safety Alerts for Medicinal Products and Medical Devices-Country Wise

Drug Safety Alerts from New Zealand Health Authority-MedSafe

Jun 25, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Medsafe- New Zealand, Pharmacovigilance, Voluntary ADR reportingCongenital abnormalities, Individual benefit-risk assessment, Medsafe, Medsafe Drug Safety Updates, New Zealand Health Authority-Drug Safety Updates, Ondansetron, oral cleft defect, Tramadol

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

Jun 18, 2020Public Safety & VigilanceDrug Safety Alert, Drug Safety Signal, Drug Safety Updates, EMA-European Medicines Agency, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, Safety CommunicationsDrug Safety Updates, EMA-June 2020, European Medicines Agency

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

Jun 17, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaOvation iX Abdominal Stent Graft Systems, Recall of Class I medical Device, USFDA Medical Device Recall

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

Jun 12, 2020Public Safety & VigilanceDrug Recall, Drug Safety Updates, Global Safety Alerts, Pharmacovigilance, USFDA-United States of America, Voluntary ADR reportingMetformin ER, Metformin ER Voluntary Recall, Metformin Extended Release, NMDA, 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: Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0

Jun 3, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaClass I medical device recall, Most serious type of medical device recall, USFDA Medical Device Recall

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

Jun 2, 2020Public Safety & VigilanceCOVID-19 Medication, Drug Safety Alert, Drug Safety Signal, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Pharmacovigilance, PvPI-India, Safety Communications, Voluntary ADR reportingDrug safety alert, Hydroxychloroquine, Mouth Ulceration, 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

Jun 1, 2020Public Safety & VigilanceDrug Safety Alert, Global Safety Alerts, Medicinal Product Updates, NPRA-Malaysia, Pharmacovigilance, Voluntary ADR reportingDrug Safety Alerts, Dysphagia, Gabapentin, Malaysian health authority, Microscopic colitis, PPI, Proton pump inhibitors

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”

May 30, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, US-FDA, USFDA-United States of AmericaClass I medical device recall, HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief, Most serious type of medical device recall, USFDA Medical Device Recall

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…

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

Apr 30, 2020Public Safety & VigilanceDrug Safety Signal, Drug Safety Updates, EMA-European Medicines Agency, Global Safety Alerts, Pharmacovigilance, Safety CommunicationsEMA Drug Safety Updates April 2020, EMA recommendations, Liver injury risk with Ulipristal acetate, Meningioma risk associated with cyproterone use

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…

Ingenol mebutate is having negative benefit to risk ratio: PRAC concludes

Apr 17, 2020Public Safety & VigilanceDrug Safety Updates, Drug Withdrawal, EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Safety CommunicationsDrug suspension, Drug withdrawal, EMA, Ingenol mebutate, Picato, PRAC Recommendation, skin cancer risk

In a new release from European Medicines Agency (EMA), Pharmacovigilance Risk Assessment Committee (PRAC) stated that ingenol mebutate may increase the risk of skin cancer and concluded that risks for ingenol mebutate medicine are greater than its benefits. On 09-May-2019, PRAC initiated the procedure of review for assessing the benefit risk profile for ingenol mebutate…

Public Safety & Vigilance

A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.