Yearly Archives: 2012

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Infant ventilator for critically ill babies recalled due to dangerous defect

The Food and Drug Administration (FDA) is warning medical staff of a deadly defect affecting a high-frequency ventilator used for ventilating critically ill infants. Specific lots of the Bunnell Life Pulse High-Frequency Ventilator Patient Circuits are being recalled because the device has been found to have a heater wire insulation that can melt, causing sparking and smoke, close to the humidifier cartridge. This defect can cause serious adverse health consequences, including death, and thus has been classified as a Class 1 recall. The Brunnell Life Pluse High-Frequency Ventilators are used for ventilating critically ill infants with pulmonary interstitial emphysema and ... Read More

Unwashed hands can affect blood sugar readings

Handling fruit before checking your blood sugar can result in too-high blood glucose level readings, according to a new report in Diabetes Care. Researchers found peeling oranges, grapes or kiwi, or even holding them in your hands, results in a residue of glucose on hands. If a finger is pricked before being washed, the glucose reading will be higher than it really is. This residue can alter glucose meter readings by as much as 10 percent. Diabetics will get a truer reading if, after pricking their fingers with a lancet, wiping away the first drop of blood and testing with ... Read More

Diabetics at greater risk for fractures

People with type 2 diabetes are at a significantly greater risk for fracture-related hospitalization, according to a large study published online in Diabetes Care. The study, which began in 1987, involved about 1,800 diabetics (including both diagnosed and undiagnosed diabetics) and 13,340 people without the disease. A total of 1,078 fracture-related hospitalizations were noted during the 20-year follow up. (The study only captured inpatient hospitalizations.) Researchers found that participants without diabetes were far less likely to be hospitalized for a bone fracture compared to diabetics. However, the fracture risk was not higher among undiagnosed diabetics. Patients on oral diabetes medications ... Read More

Defective resuscitators recalled, could cause life-threatening consequences

Manual resuscitators used to help pediatric and adult patients breathe when they are unable to do so on their own, are being recalled because of a valve leak that prevents the flow of air and may be hard to detect. The recall is categorized as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. The recall involves certain lots of Ventlab disposable, manual resuscitators. The affected devices were manufactured and distributed between March 2012 and ... Read More

New blood thinner Eliquis wins approval in Japan, but FDA has yet give clearance

Japanese drug regulators have approved the new blood thinner Eliquis from Bristol-Myers Squibb and Pfizer to prevent strokes in patients with a type of heart rhythm abnormality known as atrial fibrillation. The drug has already been approved in the European Union and Canada, but the United States has yet to give it the go-ahead, having twice rejected its bid for approval. The U.S. Food and Drug Administration (FDA) is scheduled to make a decision on Eliquis in March, and if approved, would clear the way for blockbuster status. Blockbuster status is given to drugs that reach $1 billion in sales ... Read More

Complaints allege Fresenius withheld information about deaths to minimize legal risks, keep market share

Fresenius Medical Care, the world’s largest provider of dialysis services and products, is facing numerous wrongful death lawsuits claiming one of its products caused the deaths of dialysis patients. The company is fighting back, claiming it was not at fault. But sources say top management at Fresenius knew its dialysate product GranuFlo was contributing to serious health problems including deaths in patients but withheld this information in order to maintain the company’s market share as well as to minimize and diffuse its legal risks. Dialysates, such as GranuFlo, are solutions used to clean the blood during hemodialysis. GranuFlo is the ... Read More

CPSC Gains Assistance From Four Major Retailers To Recall Nap Nanny® Recliners After More Infant Deaths

After five infant deaths, the U.S. Consumer Product Safety Commission (CPSC) and four major retailers, including, Buy Buy Baby, and Toys R Us/Babies R Us, are announcing a voluntary recall to consumers who own Nap Nanny® recliners.  This recall will involve both the Nap Nanny Generations One and Two and the Chill™ model infant recliners. Although the manufacturer, Baby Matters, LLC, has been made aware of deaths and injuries linked to their product, CPSC requested the participation of the retailers because of the manufacturer’s inability or unwillingness to participate in the recall. Baby Matters, LLC, in cooperation with ... Read More

FDA chief pushes for new laws to govern compounding pharmacies

Federal and state inspectors should work together more closely to oversee compounding pharmacies in order to prevent the distribution of contaminated medications like the ones that caused the deadly multi-state outbreak of rare fungal meningitis, said Food and Drug Administration (FDA) commissioner Margaret Hamburg. However, House Republications are showing little interest in the FDA’s plan, arguing that the FDA had numerous opportunities to close the compounding pharmacy before the outbreak began. Compounding pharmacies mix together FDA-approved drug ingredients according to doctors’ orders. Drug companies that manufacture these drug ingredients are regulated by the FDA, but oversight of compounding pharmacies is ... Read More

$1 billion Toyota settlement provides economic damages, safety upgrades to vehicle owners

A settlement to resolve economic damages stemming from sudden unintended acceleration in millions of Toyota and Lexus vehicles will provide some relief to car-owners who claim the ongoing controversy caused a significant decline in the value of their vehicles.   On Wednesday, Toyota agreed to pay as much as $1.4 billion to settle economic-loss litigation stemming from Toyota’s sudden-acceleration debacle, which led to the recall of more than 14 million vehicles worldwide. The agreement is believed to be the largest settlement in U.S. history involving automotive defects. Toyota recalled millions of vehicles in 2009 and 2010 to fix problems relating ... Read More

Abbott’s new testosterone test gets FDA clearance

The U.S. Food and Drug Administration (FDA) has approved a new method of analyzing testosterone levels in men and women. The new chemical analysis is made by Abbott Laboratories, the drug maker whose sales of Androgel testosterone-replacement gel achieved blockbuster status in recent months, earning the company nearly $900 million in 2011. According to Abbott, its new testosterone assay should help doctors more accurately measure testosterone levels, which vary widely in both men and women. Abbot reported on its website that published studies have demonstrated that many testosterone tests currently used are not sufficiently sensitive to accurately measure low testosterone ... Read More