News Tagged ‘FDA MedWatch

Drug-calcium interaction linked to death in newborns

baby bottle 100x100The Food and Drug Administration () postmarket reviews have identified serious adverse reactions that have resulted in of newborns associated with the use of ceftriaxone and calcium salt in the body. Ceftriaxone is often used in infants between 4 and 8 weeks of age who have a high fever and are admitted to the hospital.

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Cardiac device recalled due to risk of serious injury, death

balloon catheterA device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration () because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or to patients.

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FDA investigates external defibrillators for effectiveness

defibrillator 100x100External biphasic defibrillators, monitor/defibrillators and automated external defibrillators (AEDs) used to provide cardioversion therapy to patients are being investigated by the Food and Drug Administration following reports that the devices designed to deliver 200 J (joules) were ineffective during use.

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FDA recalls contaminated lots of anesthetic propofol

propofol 100x100A brand of the anesthetic propofol is being recalled by the Food and Drug Administration (FDA) because the injectable emulsion may contain particulate matter that could potentially impede blood flow and lead to serious health issues such as stroke, respiratory failure, kidney failure, liver failure, heart attack and/or stroke. The recall includes 85 lots of Hospira, Inc. brand Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80. The affected lots were distributed between July 2009 and October 2009.

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FDA cautions about adverse events, deaths associated with anemia drug

Exjade 100x100The Food and Drug Administration (FDA) is notifying hemotology-oncology providers of an ongoing review of safety issues with Exjade (deferasirox), an oral medication used to treat patients aged 2 and older with chronic anemia and iron overload as a result of receiving blood transfusions. According to the early communication, new safety data suggests there may be a greater number of adverse events and deaths in patients using Exjade who are older than 60 years of age and who have myelodysplastic syndrome (MDS), a potentially fatal condition that can require frequent blood transmissions.

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Serious neurological disorder linked to MS, Crohn’s drug

fda logo 100x100A medication used to treat multiple sclerosis (MS) and Crohn’s disease has been linked to a serious and usually fatal neurological disorder, according to an alert issued to neurological health care professionals and their patients by the Food and Drug Administration (FDA).

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FDA evaluating adverse events associated with Xolair asthma meds

xolair 100x100The Food and Drug Administration () has announced it is evaluating interim safety findings from an ongoing study of the asthma treatment Xolair (omalizumab), which suggest those who use Xolair experience a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events compared to those not treated with the drug.

Xolair is approved for use by adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

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