title: Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.
abstract: The U.S. Food and Drug Administration (FDA) periodically publishes Drug Safety Communications and Drug Alerts notifying health care practitioners and the general public of important information regarding drug therapies following FDA approval. These alerts can result in both positive and negative effects on patient care. Most clinical trials are not designed to detect long-term safety end points, and postmarketing surveillance along with patient reported events are often instrumental in signaling the potential harmful effect of a drug. Recently, many cardiovascular (CV) safety announcements have been released for FDA-approved drugs. Because a premature warning could discourage a much needed treatment or prompt a sudden discontinuation, it is essential to evaluate the evidence supporting these FDA alerts to provide effective patient care and to avoid unwarranted changes in therapy. Conversely, paying attention to these warnings in cases involving high-risk patients can prevent adverse effects and litigation. This article reviews the evidence behind recent FDA alerts for drugs with adverse CV effects and discusses the clinical practice implications.
authors.affiliation: Department of Pharmacy Practice, College of Pharmacy, Oregon State University/Oregon Health & Science University, Corvallis, Oregon.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Rackham
authors.forename: Megan
authors.initials: M
authors.lastname: C Herink
authors.forename: Ian G
authors.initials: IG
authors.lastname: Stevens
authors.forename: Natalie M
authors.initials: NM
authors.lastname: Cardoza
authors.forename: Harleen
authors.initials: H
authors.lastname: Singh
mesh_terms: D002319:Cardiovascular System / Q000187:drug effects*; D064420:Drug-Related Side Effects and Adverse Reactions; D004562:Electrocardiography / Q000187:drug effects; D006331:Heart Diseases / Q000139:chemically induced*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
keywords: Parkinson disease; arrhythmias; cardiology; drug safety; heart failure; infectious disease; patient safety; pharmacy practice; public health; toxicology