Alerts, Approvals and Safety Changes

 
 
  • REVO Pacemaker Following the advice of its advisory panel, the FDA has approved Medtronic's premarket approval application for the REVO SureScan packing system, which is designed to be safe for magnetic resonance imaging.
  • Alert New Rosiglitazone Label The new label has been changed to highlight the increased cardiovascular risks with the drug, noting that in a meta-analysis of 52 studies, most of which compared rosiglitazone with placebo, the drug was associated with a significantly increased risk of MI.
  • Alert Dabigatran Dispensed in Bottles in US Expires Within 30 Days Healthcare professionals say that patients in the US taking the new anticoagulant dabigatran should be aware that if their prescription comes in a bottle, it should be used within 30 days of opening.
  • Alert Dronedarone Linked to Liver Damage, Transplants, Says Sanofi Sanofi Aventis has sent out a letter to US healthcare professionals alerting them to an association between severe hepatic injury, including two liver transplants, and use of its anti-arrhythmic drug, dronedarone (Multaq). The company says it will also change the prescribing information for the product, although it stresses no causal association has yet been established. The FDA has also issued a
  • Absorb Available in Europe The CE Mark approval is based on the ABSORB clinical trials, previously reported by heartwire, showing the feasibility of the dissolvingdevice and the durability of its antirestenotic properties.
  • First Triple Combo With Aliskiren Gets US Approval The FDA has approved a triple antihypertensive combination therapy with a direct renin inhibitor, along with a calcium channel blocker and a diuretic, the first such combination with the inhibitor.
  • Alert Lipitor Recall Pfizer is recalling 19 000 more bottles of Lipitor for the same mystery odor reported earlier this year.
  • Cryoballoon The FDA approves Medtronic's Arctic Front cryoablation balloon catheter based on the STOP-AF trial.
  • Alert Pfizer Pulls PAH Drug Due to Liver Toxicity Pfizer announced today that it will voluntarily withdraw sitaxentan, a drug for pulmonary arterial hypertension, following two cases of fatal liver toxicity.
  • Assay for Fibrosis-Marker Galectin-3 for HF Risk Assessment The FDA has okayed an ELISA-based test for galectin-3, a biomarker thought to reflect progression of myocardial remodeling, for assessing risk in patients with chronic heart failure.
  • Alert SPL, B Braun Medical in New Heparin Recall A California heparin manufacturer, supplied by a company that played a role in the worldwide 2008 heparin recall, has announced a new recall that so far involves only seven lots of the product.
  • Alert Pfizer Recalls More Lipitor Pfizer recalls two lots of Lipitor because of customer reports of an uncharacteristic odor related to the bottles.
  • Dabigatran Approved for AF The long wait for an alternative to warfarin in the US is over. The drug will be available in two doses: 75 mg and 150 mg.
  • Alert Atorvastatin Recall Pfizer has recalled seven lots of atorvastatin (Lipitor) because of an "uncharacteristic odor related to the bottles in which the product is packaged".
  • European CHMP Recommends Ticagrelor Approval It's now up to the European Commission to decide whether to grant approval for the clopidogrel competitor.
  • Alert FDA Restricts Rosiglitazone, But EMA Suspends It After months of deliberations, the FDA has opted to allow Avandia to stay on the market, but only with severe restrictions. It also opted to stop the TIDE trial, pending a rereview of the RECORD trial. In contrast, the EMA has ordered the suspension of all rosiglitazone-containing products
  • FDA Approves New CRT-D Indications FDA follows the advice of a March advisory panel in approving new indications for Boston Scientific cardiac resynchronization defibrillators.
  • New IV Antiarrhythmic Drug Approved in EU for Rapid Conversion of AF A novel intravenous drug, vernakalant, has been approved in the European Union, Iceland, and Norway for the rapid conversion of recent-onset atrial fibrillation to sinus rhythm in adults.
  • Alert Withdrawal of Midodrine The FDA is recommending the withdrawal of midodrine hydrochloride, currently used in the treatment of hypotension, because there are insufficient data to support its benefit.
  • Alert Inferior Vena Cava Filter Risks The agency reminds clinicians that the devices should be removed as soon as it is safely possible.