Category: Drug safety alert
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Safety data of AstraZeneca’s and Oxford University vaccine phase 3 trials
Today University of Oxford and AstraZeneca researchers present a pooled analysis of Phase 3 trials of a vaccine against SARS-CoV-2 across two different dose regimens, resulting in an average efficacy of 70.4%. The new study published in the Lancet is the first peer-reviewed publication of phase 3 data from studies of a vaccine against the…
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Medical device safety information from UK MHRA
As per recent medical device safety information from MHRA, the Philips HeartStart MRx monitor/defibrillator therapy selector switch may fail, resulting in abnormal device behaviours including: the device may not perform the selected function the therapy knob may not change to the energy setting selected the device may deliver a shock with an energy level different…
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Drug safety Alert – Benadryl and serious adverse events
The U.S. Food and Drug Administration (FDA) has released drug safety communication about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl). Taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine diphenhydramine (Benadryl) can lead to serious heart problems, seizures, coma, or even death. In the communication FDA stated “We…
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Safety alert on Manasmithra pills – TGA
The Therapeutic Goods Administration (TGA), in conjunction with state health authorities, is investigating a report of the presence of dangerous levels of lead and other heavy metals in the Ayurvedic medicine Manasamitram Pills. If high levels of lead are present in these products, taking them could result in lead poisoning. Lead poisoning is a serious…
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Serious risks associated with benzodiazepine drug class
Benzodiazepines are class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder. The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately. This increases these serious risks, especially when benzodiazepines…
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Risk of serious liver injury associated with the use of Fibristal – Health Canada Advisory notice
Fibristal (ulipristal acetate) is approved in Canada to treat signs and symptoms of a type of non-cancerous tumour in the uterus (uterine fibroids) in women of childbearing age. The Department is again reviewing the risk of serious liver injury associated with Fibristal, in response to a new international case of liver injury that led to…
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Vascular Endothelial Growth Factor (VEGF) Inhibitors: Increased Risk Of Aneurysm And Artery Dissection
On July 31, 2020 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, “Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection“, which began as follows: Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients…
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First-line treatment for bipolar disorder Priadel to be discontinued in UK from April 2021
The planned discontinuation of first-line bipolar disorder treatment Priadel has caused concern that some patients could relapse and face hospitalisation. The manufacturer of first-line bipolar disorder treatment Priadel is discontinuing production of the medicine, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced — causing concerns that patients could relapse and face hospital admission. A supply disruption alert (SDA) issued by the MHRA on 21 August…
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Fournier Gangrene Associated with Sodium-Glucose Cotransporter-2 Inhibitors – study from FAERS data
Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a relatively new drug category used for type 2 diabetes mellitus treatment in adults. They prohibit the normal functions of SGLT2, which are primarily expressed in the kidney, responsible for reabsorption of glucose from the glomerular filtration back into circulation, leading to urinary glucose excretion, thus lowering blood sugar. Unlike…
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Preliminary report of an mRNA Vaccine against SARS-CoV-2
The Phase 1 of the Moderna, SARSCoV2 vaccine results published by NEJM and they are very encouraging for immune response and safety in 45 healthy people, 2 shots, increasing doses. The study is funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461). This phase 1, dose-escalation, open-label trial including…