An FDA safety review found the potential for increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine).These studies began when the FDA received reports of...
As of early March, three COVID-19 vaccines received emergency use authorization (EUAs) from the FDA. InDecember, the Pfizer/BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine received EUAs, and in lateFebruary the Johnson & Johnson/Janssen COVID-19 vaccine received an EUA. Both...
The FDA alerted clinical laboratory staff and healthcare providers that genetic variants of COVID-19 may lead to false negative results in certain diagnostic tests. This alert applies to all molecular COVID-19 tests, though the FDA continues to monitor the effect...
The FDA alerted the public that preliminary results from a safety clinical trial found an increased risk of serious heart related problems and cancer with Xeljanz (tofacitinib) and Xeljanz XR. These drugs are indicated for the treatment of rheumatoid arthritis,...
In November of 2020, the FDA issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody designed to block the coronavirus’ attachment and entry into human cells, for the treatment of mild-to-moderate COVID-19. However, in April of 2021,...
