Summary of adverse drug events for hydroxychloroquine, azithromycin, and chloroquine during the COVID-19 pandemic

Dauner DG, Dauner KN. J Am Pharm Assoc (2003). 2021 May-Jun;61(3):293-298.

The United States declared a national emergency concerning the coronavirus disease 2019 (COVID-19) outbreak on March 13, 2020, and on March 28, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the use of oral formulations of hydroxychloroquine (HCQ) and chloroquine (CQ) in …

SafetyCall Aids Clients with Amazon Disputes

Recently, we’ve been contacted by clients that have had their products pulled from Amazon after individual consumers have posted unsubstantiated allegations that their product caused them to become ill. In some cases, consumers have indicated in their product review that they needed to go to the ER but provided little detail regarding any diagnosis and/or treatment information and whether or …

Legal Aspects of Adverse Event Reporting

By Rick Kingston, President, Regulatory and Scientific Affairs

In addition to contributing to product safety, adverse event monitoring and post market product surveillance help reduce liability and risk for manufacturers and other stakeholders. In legal liability cases, manufacturers are held to a relatively high standard of care. So, when a manufacturer has a product issue and gets sued, one of …