June 14, 2009Influend Cough and Cold Products Influend Cough and Cold Products
Influend Cough and Cold Products Source: www.fda.gov January 2009 January 2009 Drug Safety Labeling Changes Source: www.fda.gov Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components. Source: www.fda.gov Recalls and Safety Alerts: Raptiva Withdrawn from the Market Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by... Source: www.accessdata.fda.gov Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Source: www.fda.gov Biosite brand Triage Cardiac Panel Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis. Source: www.fda.gov Recalls and Safety Alerts: Recall of Medtronic Ventricular Snap Shunt Catheters Medtronic Neurologic Technologies has recalled the company's Bioglide Ventricular Snap Shunt Catheter, which is a component of a shunt system that is used to treat hydrocephalus. The catheters may become detached from the snap base assembly, and tha... Source: www.accessdata.fda.gov Simponi (golimumab) Risk of serious fungal infections associated with TNF-α blockers, including Simponi (golimumab). Posted 05/28/2009 Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone (marketed as Rocephin and generics) Source: www.fda.gov Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. Source: www.fda.gov # posted by Network @ 11:57 PM
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