CardioExchange Archive

March 13th, 2013

FDA Officials Calm Concerns Over Excessive Bleeding with Dabigatran

Larry Husten, PHD

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 of bleeding associated […]

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March 11th, 2013

Devices vs. Drugs: A Distinction Without a Difference? Blogging from ACC.13

Sandeep Mangalmurti, MD, JD

How are devices regulated? Due to some quirks, the tail now wags the dog.

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February 12th, 2013

ACC and STS Break New Ground to Test TAVR for Unapproved Uses

Larry Husten, PHD

In a startling break with tradition, the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) 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 […]

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February 11th, 2013

FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec

Larry Husten, PHD

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 the committee […]

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January 28th, 2013

Getting a Read on St. Jude Leads: An Interview with Robert G. Hauser

Robert George Hauser, BS MD and John Ryan, MD

The researcher and EP who first documented problems with St. Jude next generation leads reacts to the FDA’s recent letter to the company and explains what he is doing for patients who have received these devices.

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January 16th, 2013

FDA Releases Warning Letter to St. Jude About ICD Leads

Larry Husten, PHD

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 setbacks and challenges […]

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December 28th, 2012

FDA Approves Eliquis (Apixaban) for Stroke Prevention in AF

Larry Husten, PHD

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 (AF). 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 member […]

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November 29th, 2012

Following Earlier Recall, Ranbaxy Halts Manufacturing of Atorvastatin

Larry Husten, PHD

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 […]

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November 2nd, 2012

FDA Investigation Finds No Excess Bleeding Risk for Dabigatran

Larry Husten, PHD

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 full FDA […]

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October 16th, 2012

FDA Review Raises Safety Concerns About Mipomersen

Larry Husten, PHD

An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce […]

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