The FDA’s Circulatory System Devices advisory panel today gave a tepid endorsement to Abbott Laboratories’ MitraClip device. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing…
Vena Cava Filters: Little Evidence And Wide Variation In Use
March 18, 2013 by Leave a Comment
Despite the absence of any evidence demonstrating benefit or showing how best to use them, vena cava filters (VCF) are used in most hospitals. Now a new study published in JAMA Internal Medicine suggests that this same lack of evidence results in an extremely broad rate of use in different hospitals. An accompanying viewpoint raises the question: “how could a…
FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran
March 13, 2013 by 1 Comment
Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases…
FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto)
March 4, 2013 by Leave a Comment
For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS). … In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS…
FDA Issues Warning Letter To CoreValve Investigator
February 28, 2013 by Leave a Comment
The FDA has issued a warning letter to an investigator in the Medtronic CoreValve US Pivotal Trial. The letter cites numerous serious violations relating to the treatment of subjects in the trial testing the experimental Medtronic TAVI (transcatheter aortic valve implantation) device. The violations were uncovered during an FDA inspection last summer. The subject of the FDA…
FDA Approves Second Generation MRI-Friendly Pacemaker System
February 13, 2013 by Leave a Comment
Medtronic announced today that the FDA had approved its Advisa DR MRI SureScan, a next generation pacemaker system specifically designed and tested for use with MRI scanners. The system, which Medtronic said would be launched immediately, includes the Advisa MRI device and two CapSureFix MRI SureScan leads. Click here to read the full post on Forbes….
ACC And STS Break New Ground To Test TAVR For Unapproved Uses
February 12, 2013 by Leave a Comment
In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and…
Seeking Cardiovascular Safety Data, FDA Blocks Approval Of Novo Nordisk’s Long-Acting Insulin
February 11, 2013 by Leave a Comment
The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But…
Popular Antidepressants May Put Patients At Risk For Serious Arrhythmias
January 29, 2013 by 1 Comment
In August 2011 the FDA issued a safety communication recommending that the extremely popular antidepressant citalopram (Celexa) not be used at doses greater than 40 mg/day because of a potential increased risk for serious cardiac arrhythmias associated with prolongation of the QT interval. Now a study published in BMJ lends support to this warning and suggests that…
FDA Releases St. Jude Warning Letter
January 16, 2013 by Leave a Comment
The FDA on Tuesday released the full text of a warning letter sent last week to St. Jude Medical. The company had previously disclosed the existence of the letter in an SEC filing but did not make clear the full extent of the FDA warning. The letter from the FDA is the latest in a series of…
Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path
January 3, 2013 by 1 Comment
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed…
FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF
December 28, 2012 by 4 Comments
The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest…
2012 In Review: A Bad Year For Conventional Wisdom
December 24, 2012 by 3 Comments
This was a really grim year for anyone who thought we had things pretty well figured out. Time and again conventional wisdom was thrown out the window. 2012 forced the cardiology community to reconsider what it thought it knew about HDL cholesterol, platelet function tests, aspirin resistance, triple therapy, IABP, and more. One device company,…
Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves
December 18, 2012 by 1 Comment
Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that…
Amgen Pleads Guilty To Misbranding Anemia Drug Aranesp
December 18, 2012 by Leave a Comment
Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices. The judge deferred a decision on the plea until Wednesday. When the final settlement…
Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin
November 29, 2012 by Leave a Comment
Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the…
FDA Investigation Finds No Excess Bleeding Risk For Dabigatran
November 2, 2012 by 1 Comment
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the…
DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System
November 1, 2012 by Leave a Comment
Cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. The announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had been informed of the investigation on October 26….
Guest Post: FDA Calls For X-Ray Screening Of Riata Leads And Additional Followup Studies
August 16, 2012 by 1 Comment
Editor’s Note: The following guest post is published with the permission of its author, Edward J. Schloss, MD, (Twitter ID @EJSMD) the medical director of cardiac electrophysiology at Christ Hospital in Cincinnati, OH. St. Jude’s troubled implantable defibrillator leads came under a fresh layer of scrutiny today with new FDA imaging recommendations and post-market study requirements. …
NY Times: FDA Officials Spied On Its Own Scientists
July 14, 2012 by 5 Comments
FDA officials developed “a wide-ranging surveillance operation” against a group of its own “dissident” scientists, according to a news report by Eric Lichtblau and Scott Shane in the New York Times. The surveillance program secretly recorded thousands of emails the scientists sent to each other as well as to members of congress, journalists, and, the…
Decision on Apixaban (Eliquis) Pushed Back By Three Months
February 29, 2012 by 1 Comment
Update, March 1, 5 PM: Ramsay Baghadi of the RPM Report says that the Cardiorenal committee will take up the apixaban NDA on Mary 22 and the rivaroxaban supplemental NDA for the ACS indication on May 23, but this information has not been confirmed. Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers…
FDA Revises the Safety Labeling of Statins
February 28, 2012 by 2 Comments
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…
FDA Grants Priority Review to Rivaroxaban (Xarelto) for ACS Patients
February 28, 2012 by Leave a Comment
The FDA has granted a priority review for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) in combination with standard therapy to reduce the risk of cardiovascular events in acute coronary syndrome (ACS) patients. The news was announced by Bayer and Johnson & Johnson. The FDA will now be required to respond within 6 months…
FDA Advisory Panel Gives Green Light to Qnexa Diet Pill
February 22, 2012 by 2 Comments
Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this…
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