Alerts

 
 
  • Alert Recall of LIFEPAK 20/20e The recall affects approximately 43 000 devices distributed worldwide over a five-year period starting in September 2002.
  • Alert Coumadin Samples Recalled in US BMS has voluntarily recalled a number of blister packs of Coumadin 1 mg provided as samples in the US, because they may not contain the right amount of an additive, isopropanol. There is little clinical risk from this situation, the company says.
  • Alert FDA Conducts Safety Review of Antihypertensive ARB Olmesartan There were cautionary signals in two placebo-controlled hypertension trials; still, the agency says, it believes the benefits of the drug, marketed by Daiichi Sankyo as Benicar, "outweigh its potential risks."
  • Alert Recall of Cardiac Science AEDs The safety alert affects approximately 280 000 devices made by Cardiac Science Corporation, the primary dysfunction being a failure to deliver a shock during the resuscitation attempt.
  • Alert Recall of LIFEPAK 15 The recall affects the monitor/defibrillators manufactured and distributed between March 26, 2009 and December 15, 2009.
  • Alert New Heparin Less Potent The FDA issued the safety communication today and is warning healthcare professionals that both the old and new formulations of heparin will be available for some time.
  • Alert Major ICD, CRT-D Retrieval by Boston Scientific Day 2 of the ACC/i2 Summit was abuzz, not with meeting news, but over the ICD/CRT-D retrieval announced Monday morning.
  • Alert AB5000 Recall Abiomed is repairing some AB5000 circulatory-support devices as part of a class I recall triggered by computer problems that cause it to shut down without warning.
  • Alert Thomas Medical Recalls Transseptal Sheath Introducer Kits Five adverse events reports of tip fragmentation and separation prompted the company action.
  • Alert Saquinavir and Ritonavir: Arrhythmia Risks Preliminary data suggest that the combination of saquinavir and ritonavir may cause prolongation of the QT and PR intervals, leading to an increased risk of torsades de pointes and heart block, respectively.
  • Alert Cardiac Science Recall Cardiac Science is initiating a worldwide recall of eight models of automated external defibrillators after internal quality testing showed that they may not be able to deliver therapy during a resuscitation attempt.
  • Alert Thomas Recall Thomas Medical is recalling certain lots of its SafeSheath CSG lead introducers in response to reports of fragmentation and embolization of the tip.
  • Alert Medicines Company Recalls 11 Lots of Calcium-Channel Blocker Cleviprex The company is voluntarily recalling the drug after noticing tiny particles of stainless steel in the injectable emulsion.
  • Alert Meridia, Reductil, SCOUT, Obesity An early analysis for the randomized placebo-controlled trial's primary end point, a composite of cardiovascular events, found a "higher than expected" rate of increase among those getting the appetite suppressant. The trial enrolled a population with a high CV risk, many of whom would not generally be recommended for the drug according to its current labeling.
  • Alert Cardiologists Shocked by New FDA Alert on Clopidogrel-PPI Interaction The FDA has issued a new warning on an interaction between clopidogrel and the PPI omeprazole and other drugs that inhibit the CYP2C19 enzyme.
  • Alert FDA Seeking Information on External Defibrillator Energy Levels The agency is following up on 14 reports over the past three years of unsuccessful defibrillation/cardioversion attempts from a 200-J device followed by successful therapy from a 360-J unit.
  • Alert Edwards Recalls Aortic Catheters Edwards's September 24 recall of balloon catheters used in bypass surgery has been categorized as a class I recall by the FDA.
  • Alert Philips Recalls Heartstart FR2+ Defibrillators The automatic external defibrillators were distributed by Philips Medical and Laerdal Medical with model numbers M3860A, M3861A, M3840A, and M3841A.
  • Alert Heparin Standards The Food and Drug Administration is asking clinicians to be aware of the change, particularly in settings where an immediate anticoagulant effect is clinically important.
  • Alert Recall of LIFEPAK AEDs The Food and Drug Administration issued a class I recall of the LIFEPAK CR Plus automated external defibrillators (Physio-Control, Redmond, WA) [1]. The recall affects models manufactured and distributed from July 9, 2008 through August 19, 2008.