November 4th, 2012
The Benefits of Technology
Eiman Jahangir, MD
Dr. Eiman Jahangir sorts through the AHA schedule in minutes using their mobile app and wonders why the AHA still bothers printing the full program booklet. Do you think there should be a way to opt out of receiving the whole schedule on paper?
November 3rd, 2012
ALTITUDE Autopsy Shows What Went Wrong With Aliskiren
Larry Husten, PHD
In its short lifespan the direct renin inhibitor aliskiren (a.k.a., Rasilez or Tekturna) rapidly declined from being a highly promising, first-of-its kind drug to a major failure. The death blow was struck last December with the early termination of the ALTITUDE trial, after the data and safety monitoring committee found an increased risk in patients taking aliskiren. Now the final results […]
November 3rd, 2012
Rivaroxaban Gains FDA Indications for Treating and Preventing DVT and PE
Larry Husten, PHD
The FDA has expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk for recurrent DVT and PE. The oral anticoagulant is already approved to reduce postsurgical risk for DVT and PE after hip- and knee-replacement surgery and to […]
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 […]
November 1st, 2012
DOJ Investigating Abiomed for Improper Marketing of Impella Circulatory Support System
Larry Husten, PHD
The U.S. Attorney’s Office is investigating Abiomed’s marketing and labeling of the Impella 2.5 circulatory support device, the company announced on Thursday. Abiomed also said that it believed that the FDA would begin a review to possibly reclassify its Impella devices as Class III devices, which would require FDA clearance using the more stringent premarket […]