CardioExchange Archive

September 1st, 2011

How Is TAVI Like a European Toaster?

Richard A. Lange, MD, MBA and L. David Hillis, MD

Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the “CE mark” — a mandatory conformity stamp for products placed on the market in the European Economic Area. Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the FDA […]

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June 24th, 2011

FDA Recommends More-Conservative Dosing of ESAs

Larry Husten, PHD

The FDA today said that it was recommending more-conservative dosing of ESAs (erythropoiesis-stimulating agents) in patients with chronic kidney disease (CKD). The possible beneficial effects of the drugs to decrease the need for transfusions in CKD patients should be weighed against the increased risk for cardiovascular events, the FDA said. ESA therapy should be given at […]

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June 16th, 2011

FDA: Varenicline (Chantix) May Increase Risk for CV Events

Larry Husten, PHD

The FDA said that the anti-smoking drug varenicline (Chantix) may increase the risk for cardiovascular events in people who already have cardiovascular disease. The new information will be added to the drug’s label and Medication Guide for patients. The FDA does not recommend that people with cardiovascular disease stop taking varenicline, but it says that physicians […]

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June 16th, 2011

FDA Says Pioglitazone Use Is Linked to Bladder Cancer

Larry Husten, PHD

The FDA has issued a safety announcement stating that the use of pioglitazone (Actos) for more than 1 year may be  associated with increased risk for bladder cancer. The FDA announcement follows last week’s suspension of the drug in France and Germany by regulatory authorities in those countries. The FDA said that pioglitazone should not be […]

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June 12th, 2011

CardioExchange Panel: Whither High-Dose Simvastatin?

CardioExchange Editors, Staff

Last week, the FDA issued a warning high-dose simvastatin because of the risk of myopathy. CardioExchange got the reactions from a panel we assembled. Whose views do you agree with? What points did our panelists miss? See a similar panel’s reactions the publication of the SHARP Trial here. Given the FDA warning, do you see any role […]

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April 26th, 2011

FDA Briefs: New Stent Approved, Advisory Committee Meeting on ACCORD Lipid

Larry Husten, PHD

Boston Scientific said on Monday that it had received FDA approval for a third-generation drug-eluting stent, the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System. The “unique platinum chromium (PtCr) alloy” is specifically designed for use in the coronary arteries. The FDA announced that the Endocrinologic and Metabolic Drugs Advisory Committee would meet on May 19 to […]

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March 2nd, 2011

FDA Finds No Increased Risk For MI With Abacavir

Larry Husten, PHD

An ongoing safety review by the FDA of the antiviral medication abacavir found no evidence for an increased risk for MI associated with the drug. The FDA said an increased risk for MI with abacavir had been seen in several observational studies and one randomized controlled trial (RCT), but not in other RCTs or in […]

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February 8th, 2011

FDA Approves First Pacemaker Designed For Use with MRI

Larry Husten, PHD

The FDA has approved Medtronic’s Revo MRI SureScan Pacing System, the first pacemaker designed for safe use during MRI exams. Here is Medtronic’s description in a press release of how the pacemaker differs from traditional pacemakers: “The pacemaker system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards […]

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January 14th, 2011

FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)

Larry Husten, PHD

The FDA has released a safety communication about severe liver injury associated with Multaq (dronedarone). The FDA said that information about the risk of liver injury would be added to the dronedarone label. The drug’s manufacturer, Sanofi-Aventis, has also sent a letter to healthcare professionals informing them of the warning. The FDA is recommending that doctors advise […]

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November 19th, 2010

Darvon and Darvocet Withdrawn from U.S. Market

Larry Husten, PHD

The FDA announced today that Xanodyne Pharmaceuticals had agreed to withdraw Darvon and Darvocet from the U.S. market. The drugs contain the opioid propoxyphene, which the FDA said “puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.” The FDA said it had asked generic manufacturers of propoxyphene to withdraw their products also.

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