February 08, 2021 – In the period of the Covid-19 pandemic and the emerging spectrum of severe adverse (drug) reactions (SADRs) of the anti-Covid-19 vaccines in some patients receiving these vaccines, one easily forgets about the same phenomenon of SADRS …

Fingolimod (Gilenya): Warnings on severe liver failures Read more »

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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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April 30, 2013 –   The U.S. Food and Drug Administration (FDA) has determined that the drug Tolvaptan (Samsca) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can …

FDA limits duration and usage of Tolvaptan (Samsca) due to possible liver injury leading to organ transplant or death Read more »

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January 14, 2011 – The American Food and Drug Administration (FDA) notified today healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with …

Heart Medication Dronedarone [Multaq]: Risk of Severe Liver Injury Read more »

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December 13, 2010 – We learn today that the European Medicines Agency (EMEA) has been informed of Pfizer’s decision to voluntarily withdraw Sitaxentan [Thelin] from the market worldwide further to new information on two cases of fatal liver injury. Pfizer …

Sitaxentan [Thelin] to be withdrawn from market worldwide due to cases of unpredictable serious liver injury Read more »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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