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NSF study finds link between Gadolinium used in MRI and debilitating disease

Another Nephrogenic Systemic Fibrosis (NSF) study has tied the debilitating condition to Gadolinium contrast agents used in Magnetic Resonance Imaging (MRI). This latest NSF research was conducted by the Centers for Disease Control (CDC), which examined a cluster of NSF patients at one unidentified St. Louis Missouri Hospital. The CDC found that the exposure to Gadolinium contrast dyes during MRI was independently associated with the development of NSF. NSF (sometimes called Nephrogenic Fibrosing Dermopathy or NFD) was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue ... Read More

Poor FDA scrutiny of Medtronic Sprint Fidelis lead

The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it comes to defective implantable medical devices. That’s because the number of medical devices meant to be implanted in patients’ bodies is rapidly rising. Unfortunately, despite their rising numbers, as the case of the Sprint Fidelis Lead recall illustrates, the Food & Drug Administration (FDA) is doing a poor job of regulating implantable devices, and often ignores reports of device failures until someone dies. Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead ... Read More

Avandia study shows increased heart risks or death

Older patients who took Avandia had a higher risk of heart attacks, congestive heart failure and death than those on other diabetes pills, according to a study of nearly 160,000 Canadians. For four years, the study followed patients over age 65, who have the highest rate of type 2 diabetes but aren’t well represented in clinical trials, says lead author Lorraine Lipscombe, a Toronto endocrinologist and researcher at the Institute for Clinical Evaluative Science, funded by the Ontario government. Lipscombe’s team looked at how patients fared on Avandia or Actos, the only two drugs in their class, compared with those ... Read More

Medtronic settles defective defibrillator lawsuits for $114 Million

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation. Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the ... Read More

Avandia heart attacks seen in general patient population

The consequences of deadly Avandia side-effects are now being seen in the general population, a new study has found. Previously, evidence that Avandia placed patients at an increased risk of heart attacks had only been seen in clinical trials. But now, Canadian researchers have found that patients taking the controversial diabetes drug who are not enrolled in clinical trials are showing increased evidence of heart attacks and other cardiac problems. Avandia’s heart attack link came to light when an analysis of 42 clinical trails published by the Cleveland Clinic in May showed that patients taking the drug had a 43% ... Read More

Avandia risks highlighted

Canadian researchers furnished the strongest evidence to date linking the popular diabetes drug Avandia to an increased risk of heart attack in a scientific study released yesterday. Compared with other diabetes pills, Avandia’s use was associated with a 60 percent higher risk of heart failure, 40 percent higher risk of heart attack and 30 percent higher risk of death in patients 65 and older, the researchers found. “The risks associated with these drugs may outweigh the benefits, at least for older populations,” said Dr. Lorraine L. Lipscombe, the lead author of the study and a researcher at a health research ... Read More

New Avandia study reaffirms heart risk

Older patients who took Avandia had a higher risk of heart attacks, congestive heart failure and death than those on other diabetes pills, according to a study of nearly 160,000 Canadians out Wednesday. For four years, the study followed patients over age 65, who have the highest rate of type 2 diabetes but aren’t well-represented in clinical trials, says lead author Lorraine Lipscombe, a Toronto endocrinologist and researcher at the Institute for Clinical Evaluative Science, funded by the Ontario government. Lipscombe’s team looked at how patients fared on Avandia or Actos, the only two drugs in their class, compared with ... Read More

Diabetes drug Avandia could weaken bones

Avandia, a drug used by millions of diabetes patients, may contribute to bone loss, according to a new study conducted in mice. Experts fear that, over the long term, Avandia (rosiglitazone) may speed osteoporosis, the thinning of the bones that can lead to dangerous and even fatal fractures. The findings appear in the Dec. 2 online issue of Nature Medicine. “Our study suggests that long-term rosiglitazone usage in the treatment of type II diabetes may cause osteoporosis due to both increased bone resorption and decreased bone formation,” said study senior author Ron Evans, a professor at the Salk Institute for ... Read More

Medtronic investigations initiated by federal government

Medtronic, Inc. has acknowledged that they are the subject of multiple federal investigations regarding their marketing practices and the recent Sprint Fidelis defibrillator lead recall. The Senate Finance Committee and the Justice Department have both asked the company for information as part of investigations of wrongdoing. They also face thousands of potential lawsuits from individuals who received one of the defective wires, which are used to connect implantable defibrillators to the heart. It was reported yesterday in the Wall Street Journal that the global medical device manufacturer acknowledged the federal investigations as part of a filing with the SEC (Securities ... Read More

Medtronic faces investigations over defective Sprint Fidelis Defibrillator lead

Medtronic, Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, is the now the subject of two separate investigations. A Senate panel wants information about Medtronic’s October Sprint Fidelis Defibrillator Lead recall, while a second investigation by the US Justice Department is looking into allegations that Medtronic made illegal payments to foreign physicians. Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s ... Read More