December 28, 2020 – Some 95% of people have gene variants that may negatively affect their response to at least one drug, leading to unexpected or adverse drug reactions (ADRs) or, if unlucky, to a serious, if not fatal, adverse …

Genetics behind some serious adverse drug reactions (SADRs) Read more »

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March 10, 2020 – A widespread assumption is, the people of Asian descent are more prone to serious, sometimes deadly adverse drug reactions, even when taking rather common medications prescribed for gout through to depression. In the ages of genetics …

Are Asians at higher genetic risk of serious adverse events to common medications? Read more »

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May 30, 2019 – The American Food and Drug Administration (FDA) recently approved Alpelisib (Piqray) to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor …

The PI3K inhibitor Alpelisib (Piqray) for progressing breast cancer in women (and men) Read more »

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March 21, 2017 – Health Canada just communicated this important safety information: Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) under treatment of patients with Pembrolizumab (Keytruda) have been reported internationally in the clinical trials and post-marketing setting. …

Risk of severe if not fatal skin reactions with Pembrolizumab (Keytruda) Read more »

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September 26, 2016 – Toxic epidermal necrolysis (TEN), also known as Lyell’s syndrome, is a rare, life-threatening skin condition that is usually caused by a reaction to drugs. The disease causes the top layer of skin (the epidermis) to detach from the lower layers of the skin …

Recent advances of pharmacogenomics in severe cutaneous adverse reactions: immune and nonimmune mechanisms Read more »

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October 10, 2013 – Very recently, David Kerr, Professor of Cancer Medicine at University of Oxford, in the United Kingdom, and past President of the European Society for Medical Oncology, talked on Medscape (see the video here) about risk-benefit analyses …

Can We Identify Risk for Drug Toxicity? Read more »

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May 09, 2013 – This is from the News and Press Release Archive of the European Medicines Agency (EMA) as of April 29, 2013.  Find here the unedited release in full: 29/04/2013 Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh …

EMA: Recommendation to suspend tetrazepam-containing medicines Read more »

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February 21, 2010 – In the field of pharmaco- and toxicogenetics of serious adverse drug reactions (sADRs) in humans, we learn today from a press release by the US Food and Drug Administration (FDA) of the completion and release by …

Regulatory Science Update: FDA and International Serious Adverse Events Consortium (SAEC) Complete Third Data Release Read more »

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