July 12th, 2012
FDA Issues Class I Recall of Cardiovascular Diagnostic Tests
Kristin J. Kelley, CardioExchange Staff
The FDA announced on Wednesday a Class I recall of several lots of cardiovascular diagnostic tests aiding in the triage of heart failure, MI, and pulmonary embolism. According to the agency, the affected products do not provide the precision described in the package insert, which could lead to potentially fatal false-positive and false-negative test results. The […]
June 25th, 2012
Selections from Richard Lehman’s Literature Review: June 25th
Richard Lehman, BM, BCh, MRCGP
This week’s topics includes articles on industry regulation, the chronically comorbid, population risk for CV disease, and recombinant tissue plasminogen activator (rt-PA) for ischemic stroke.
May 10th, 2012
FDA Advisory Panel Recommends Approval for Weight Loss Drug Lorcaserin
Larry Husten, PHD
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of lorcaserin (Lorqess, Arena). The vote was 18 in favor of approval, 4 against, and 1 abstention.
May 7th, 2012
Politics and Transcatheter Aortic Valve Replacement
Larry Husten, PHD
Larry Husten takes to task a conservative activist who is trying to inject politics where it’s neither needed nor wanted.
May 2nd, 2012
Real-World Experience with TAVI: Vive la France!
Richard A. Lange, MD, MBA and L. David Hillis, MD
A study of data from FRANCE 2, a prospectively maintained, multicenter registry of the French national experience with transcatheter aortic valve implantation (TAVI), has now been published in the New England Journal of Medicine. The registry captured every TAVI performed at all 34 active centers in France and Monaco; it therefore reflects “real-life” experience with TAVI in patients with […]
March 1st, 2012
Decision on Apixaban (Eliquis) Pushed Back By 3 Months
Larry Husten, PHD
Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers Squibb announced on Wednesday evening that the FDA had extended by 3 months the action date for the new drug application (NDA) for the highly anticipated oral anticoagulant apixaban (Eliquis). The application is for their important indication of stroke prevention in atrial fibrillation. The […]
February 28th, 2012
FDA Revises the Safety Labeling of Statins
Larry Husten, PHD
The FDA today announced important new changes to the safety language on the labels of statins: Routine periodic monitoring of liver enzymes is no longer recommended. Serious liver injury associated with statins is “rare and unpredictable in individual patients” and “routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side […]
December 30th, 2011
CYP2C19 Genotyping: Down For The Count?
Richard A. Lange, MD, MBA and L. David Hillis, MD
The controversy over the use of genetic testing to guide antiplatelet therapy reminds us of a WWF (Worldwide Wrestling Federation) tag team match. What we agree upon (the match rules): Clopidogrel is a prodrug activated by several enzymes, including CYP2C19, and common genetic variations alter CYP2C19 activity. Here’s where the wrestling match begins: Are the CYP2C19 genetic […]
December 19th, 2011
FDA Adds New Warnings to Dronedarone (Multaq) Label
Larry Husten, PHD
In an updated safety communication, the FDA announced on Monday that it is adding new warnings to the dronedarone (Multaq, Sanofi) label. On the basis of results from the PALLAS trial, which was discontinued early due to safety concerns, the drug label will now warn: Healthcare professionals should not prescribe Multaq to patients with AF who cannot […]
December 7th, 2011
FDA Undertakes Safety Review of Dabigatran (Pradaxa)
Larry Husten, PHD
The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of bleeding […]
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