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…
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…
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…
Health Canada has released a new drug safety information/alert 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 – May 2020. The safety concern discussed below in brief. Hypofibrinogenaemia associated with Tigecycline use: Tigecycline is a…
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…
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…
Metformin is a prescription drug and a first line medication used to control high blood sugar in patients with type 2 diabetes. N-Nitrosodimethylamine is a probable human carcinogen which is not harmful when present within the permitted limits. Exposure to some level of nitrosamines is quite common, as these nitrosamines presence are common in water…
Hyperacusis is new drug safety signal identified for Tramadol drug by UMC (Uppsala Monitoring Center), a WHO Collaborating Centre. Hyperacusis is a rare hearing disorder which is characterized by an increased sensitivity to certain frequencies and volume ranges of sound. This disorder makes it hard to deal with everyday sounds and causes an intolerance to…
Photosensitivity reaction, a new drug safety signal for midostaurin identified based on the safety evidence from French pharmacovigilance database, the Base Nationale de Pharmacovigilance (BNPV) and from the global drug safety database, VigiBase which is maintained by WHO-UMC (Uppsala Monitoring Center). Midostaurin is a multiple tyrosine kinase inhibitor (including FLT3 and KIT kinases) which inhibits mast…
A new drug safety signal was triggered from the WHO’s global drug safety database for pharmacovigilance activities. This signal was identified by the UMC (Uppsala Monitoring Center), a WHO Collaborating Centre for international service and scientific research within the field of pharmacovigilance. Agomelatine Agomelatine is an atypical antidepressant medication used to treat major depressive disorder.…