January 26, 2021 – To date, a rare serious adverse (drug) reaction (SADR) has been noted to be associated with the first two Covid-19 vaccines, i.e., the one from Pfizer-BioNTech and the one from Moderna. We are talking about anaphylaxis, which …

Rare cases of anaphylaxis with COVID-19 vaccines Read more »

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 »

September 30, 2017 – Obeticholic acid (Ocaliva) was approved by the American Food & Drug Administration (FDA) in May 2016 for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult  patients with an inadequate response …

Obeticholic Acid (Ocaliva): Is there a serious drug safety problem? Read more »

May 17, 2017 – Following up on an earlier Drug Safety Communication from May 2016 and based on new data from two large clinical trials, the American Food & Drug Administration (FDA) has concluded that the type 2 diabetes medicines …

Risk of leg and foot amputations under Canagliflozin (Invokana, Invokamet) Read more »

May 11, 2016 – We do learn from a very recent Drug Safety Communication (DSC) by the American Food & Drug Administration (FDA) that olanzapine, the pharmacologically active component in Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, Symbyax, and olanzapine generics may cause …

DRESS: Rare but serious skin reaction with Zyprexa (Olanzapine) Read more »