Alerts

 
 
  • Alert NIH Pulls Plug on AIM-HIGH Trial With Niacin A trial of extended-release niacin on top of statin therapy in patients with a history of CVD, high triglycerides, and low levels of HDL cholesterol has been halted prematurely, 18 months ahead of schedule, because niacin offered no additional benefits in this patient population.
  • Alert Long-Awaited Rosiglitazone Risk-Management Strategy Released The agency's new risk evaluation and mitigation strategy will require, among other things, special certification for providers who want to prescribe the drug and pharmacies that want to sell it.
  • Alert Mitraclip Recalled Due to Problems With Delivery System There have been three incidents in which a radiopaque ring has become detached when the catheter was withdrawn. One patient has died following surgical intervention to retrieve the ring.
  • Alert Certain Lifeline and ReviveR AEDs Recalled The recall was prompted by rare situations in which the AED cancels the intended shock during the charging process. A software upgrade can solve the problem, the company says.
  • Alert Olmesartan Benefits Outweigh Potential CV Harms, Says FDA In an alert issued today, the FDA said it "has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure."
  • Alert FDA Says Bottled Dabigatran Good for 60 Days Almost two months after heartwirereported on the little-known 30-day expiry date for dabigatran dispensed in bottles, the FDA says its own review suggests the drug maintains its potency for at least 60 days.
  • Alert Lots of Jantoven, other agents recalled Upsher-Smith has expanded its recall from one lot to 16 lots of its Jantoven brand of warfarin sodium and has added lots of amlodipine and other drugs.
  • 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
  • Alert Lipitor Recall Pfizer is recalling 19 000 more bottles of Lipitor for the same mystery odor reported earlier this year.
  • 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.
  • 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.
  • 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".
  • 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
  • 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.
  • Alert Three Older ICD Models Could Have Problems, Says Boston Scientific A number of Boston Scientific ICDs manufactured in 2006 and 2007 could have problems with a magnetic switch, meaning they potentially might not deliver shocks when necessary, the company told the Reuters news agency yesterday.
  • Alert US Agency Will Review ARBs for Possible Cancer Risk The US FDA has become the latest regulatory agency to say it will investigate a possible link between angiotensin-receptor blockers and cancer.