Alerts

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
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
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
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
Alert Excess Radiation With CardioGen-82 So far the FDA has received 2 reports of patients who received more than the expected radiation dose from the strontium-based isotope used with this scanner.
News, July 15, 2011
Alert Varenicline May Raise CV Events in CVD Patients: FDA The new safety communication states that physicians need to balance known benefits of varenicline--a drug effective in helping patients quit smoking--with the potential risks when deciding to use the drug in patients with cardiovascular disease.
News, June 16, 2011
Alert IABP, Cannulae, and IVUS Recalls Now Class I: FDA FDA has officially categorized several recent device recalls as class I, indicating the device defects pose a potentially lethal risk.
News, June 15, 2011
Alert Pioglitazone for 1 Year May Increase Risk of Bladder Cancer In the FDA's announcement today, the agency stated that information on the drug's label, as well as the patient medication guide, will be revised to include this new information.
News, June 15, 2011
Alert FDA Restricts Use of Simvastatin 80 mg In the SEARCH trial--the basis for the FDA review--52 patients taking the 80-mg dose developed myopathy compared with one patient treated with the 20-mg dose. In addition, 22 patients treated with the high dose of simvastatin developed rhabdomyolysis compared with none treated with the 20-mg dose.
News, June 08, 2011
Alert FDA Review Concludes: No Cancer Risk With ARBs An FDA review launched in the wake of a controversial 2010 meta-analysis has concluded that the drugs do not pose a cancer risk to patients. The FDA says it conducted a much larger, more comprehensive review of the data to reach its reassuring conclusions. Not everyone, however, is satisfied.
News, June 02, 2011
Alert Boston Scientific iCross IVUS Catheter Recalled The class I recall affects all iCross IVUS catheters distributed in the US, Puerto Rico, Trinidad and Tobago, and the US Virgin Islands.
News, May 31, 2011

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