Alerts, Approvals and Safety Changes

Alert Ticagrelor (Brilinta) Professional Samples Recalled, 1 Lot One lot of sample bottles with eight 90-mg tablets of the widely used antiplatelet is being recalled after reports that one such bottle also contained pills of a drug for gout.
News, May 26, 2017
Arrow Recalls Intra-Aortic Balloon Catheter Kits The class I recall of specific lot numbers, of which hospitals were informed last month, was due to the potential for a hardware failure and consequent risk of bleeding.
News, March 11, 2016
Alert Almost 50 000 Vials of IV Nitroglycerine Recalled Baxter International is voluntarily recalling one lot of its Nitroglycerine in 5% Dextrose injection after finding particulate matter in a single vial.
News, November 27, 2013
Alert Europe's CHMP: Restrict IV Nicardipine to Proven Scenarios Nicardipine had been used in some EU countries for controlled hypotension during anesthesia and in the setting of LV decompensation and pulmonary edema. No more, an EMA review has recommended.
News, October 25, 2013
Alert CardioGen-82 Returns to Market For its return, the FDA-approved revised labeling for CardioGen-82 includes a new boxed warning. The label warns of unintended radiation exposure when levels of Sr-82 and Sr-85 in the rubidium Rb-82 chloride injection exceed limits.
News, February 16, 2012
Alert US Dabigatran Label Updated With Renal Function Advice Revisions to the label also include information on the storage and handling of dabigatran and recommendations on use with other medications, such as dronedarone and systemic ketoconazole. Open bottles of the drug can now safely be stored for four months.
News, November 09, 2011
Alert FDA Issues 'Safety Communication' on Fenofibrate The agency has updated the prescribing information for the cholesterol-lowering agent, stating that it may not lower the risk of major cardiovascular events, and is requesting Abbott to conduct another study.
News, November 09, 2011
FDA Approves Rivaroxaban for Stroke Prevention in AF Patients The approved indication of prevention of stroke and systemic embolism in nonvalvular atrial fibrillation is based primarily on the results of ROCKET-AF.
News, November 04, 2011
Alert EMA Reviewing Safety of NSAIDs, Clarifies on Pioglitazone The EMA has launched a new review of the cardiovascular safety of NSAIDs, while also clarifying a previous opinion on the use of the antidiabetic agent pioglitazone and the risk of bladder of cancer.
News, October 21, 2011
Alert EMA Review Concludes: No Cancer Risk With ARBs The European Medicines Agency "concludes that benefit/risk balance of angiotensin-II-receptor antagonists remains positive," a press release from the agency states today.
News, October 20, 2011
FDA Approves Diabetes and Cholesterol-Lowering Drug Combo Known as Juvisync, the new medication combines sitagliptin, a dipeptidyl peptidase-4 inhibitor used for glycemia control, with the cholesterol-lowering simvastatin.
News, October 07, 2011
Alert Dabigatran: Australia Issues Bleeding Warning The Australian regulatory authority has issued a "safety advisory" on the new oral anticoagulant dabigatran because of an increase in the number of bleeding-related adverse events reports received since it was approved for use in AF patients.
News, October 07, 2011
Alert EMA Recommends Restricting Use of Dronedarone The EMA committee states that because of the increased risk of liver, lung, and cardiovascular adverse events, dronedarone "should only be prescribed after alternative treatment options have been considered."
News, September 22, 2011
Alert Deaths Prompt Dabigatran Safety Advisory in Japan According to Boehringer Ingelheim, treatment with Prazaxa, as it is known in Japan, could not be completely ruled out as a cause of death in five patients, one of whom had kidney failure (a contraindication) and four of whom were aged over 80.
News, August 17, 2011
Alert New Pioglitazone Label Highlights Bladder-Cancer Risk The updated label states that pioglitazone should not be started in patients with active bladder cancer and should be used with caution in patients with a prior history of bladder cancer.
News, August 05, 2011
EU Approves Dabigatran for AF Indication The warfarin alternative will be available in the 150-mg and 110-mg strengths for twice-daily administration, as studied in the RE-LY trial.
News, August 04, 2011
Alert Stop Using the Cardiogen-82; Scanner Recalled What was a radiation "breakthrough problem" two weeks ago is now a device recall, the FDA says in an alert today.
News, July 26, 2011
Alert FDA Updates Label for Chantix The label warns physicians that while varenicline is effective in helping patients with cardiovascular disease quit smoking, it is also associated with a small increased risk of cardiovascular adverse events in this patient population.
News, July 25, 2011
Alert EMA Updates on Pioglitazone and Varenicline The European drug regulator is recommending a label change for one drug, and a stay-the-course message for the second.
News, July 22, 2011
Alert Deaths Doubled With Dronedarone in PALLAS: FDA, EMA Updates Both drug safety regulators issued alerts today noting that they are considering new, preliminary information provided from the PALLAS study in their ongoing safety review of the drug.
News, July 21, 2011

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