Posts Tagged ‘FDA’

February 3rd, 2014

FDA Evaluating Safety Of Testosterone Products

The FDA has announced that it is evaluating the cardiovascular safety of testosterone products. The investigation is prompted by two recent published studies that found a significant increase in cardiovascular events in men who received testosterone therapy. The FDA said it had not concluded that testosterone is unsafe but recommended that “health care professionals should consider […]

January 24th, 2014

Stent Remains Available Despite Trial Showing Dangers

A leading critic says that the FDA has been remiss for not removing a stent from the market although strong evidence exists that its use leads to more deaths and strokes. The Wingspan intracranial stent, manufactured by Stryker Neurovascular, was approved in 2005 by the FDA through the humanitarian device exemption (HDE) for the rare condition […]

January 3rd, 2014

FDA Plans New Safety Assessment of Dabigatran (Pradaxa)

Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the U.S. in 2010 there have been persistent and lingering concerns about the drug’s safety. Now the FDA plans to perform a large new assessment of the drug compared to warfarin. On December 30 the FDA posted a request for public comment on a proposed […]

December 16th, 2013

Possible New Lease on Life for Vorapaxar and Rivaroxaban for ACS

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and […]

November 25th, 2013

FDA Removes Restrictions on Avandia

In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of  intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said its […]

November 25th, 2013

FDA Reprimands 23andMe, Grants Breakthrough Status to Factor Xa Inhibitor, and Approves Promus Premier Stent

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe: FDA Halts 23andMe Personal Genome Test: The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.  The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including […]

November 7th, 2013

FDA Seeks to Eliminate Trans Fat from Food in the U.S.

The FDA said today that it would begin to take efforts to remove trans fat from food in the U.S. The agency has made the “preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not ‘generally recognized as safe’ for use in food.” If the FDA’s preliminary determination is made final then manufacturers […]

October 18th, 2013

FDA Approves New Pulmonary Hypertension Drug from Actelion

The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease progression in patients who have pulmonary arterial hypertension (WHO Group I). Last August the results of the pivotal phase 3 trial, SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary […]

September 23rd, 2013

Using Registry Data, FDA Expands Indication for Edwards’ Sapien Transcatheter Heart Valves

Relying on an important new source of information, the FDA said today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously, the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points […]

August 26th, 2013

Missing Data And The ATLAS ACS 2-TIMI 51 Trial


What is the impact of the larger than usual amount of missing data in the ATLAS ACS 2-TIMI 51? A member of the FDA’s Cardiovascular and Renal Drugs Advisory panel answers questions about this issue.