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Possible good news for medtronic defibrillator patients with defective leads

The Medtronic recall and the concern being expressed about the St. Jude Riata leads has left patients in fear that they have defective defibrillator lead wires in their chest that cannot be removed. Both Medtronic and the FDA have suggested that for most patients, removing the leads is not the best option because of the risks associated with the removal. The good news, according to a recent article in Medical Device Week, is that medical technology is moving towards a safe and effective way to remove leads if they become damaged or dangerous to the patient. Leads can become hazardous ... Read More

Diabetes drug may increase bone thinning

The popular diabetes drug marketed as Avandia may increase bone thinning, a discovery that could help explain why diabetics can have an increased risk of fractures. New research raises the possibility that long-term treatment with rosiglitazone, as Avandia is also called, could lead to osteoporosis. The diabetes drug is used to improved response to insulin. While bones seem solid, they constantly are being broken down and rebuilt by the body. Researchers found that in mice, the drug increased the activity of the cells that degrade bones, according to a report in this week’s online issue of Nature Medicine. Avandia recently ... Read More

Medtronic should be honest about Sprint Fidelis leads

Jane Adams has been dealing with Medtronic since 1999. Prior to having her defibrillator implanted, she trusted the medical device company. However, since a defibrillator with Sprint Fidelis leads was implanted, Adams says she has lost faith in them. “My pacemaker was implanted in 1999. It worked very nicely and it turned my life around,” Adams says. “But my heart was wearing out and I needed to have a defibrillator put in. After a discussion with my electrophysiologist I decided to have the defibrillator put in on the left side. I made that decision based on how long these devices ... Read More

Speak out!

As for people with family in nursing homes, Kathleen Sadlier says to be careful. “If you have someone there, really keep an eye on everything to see what is going on. Don’t just think they are being taken care of, because they might not be. I feel sorry for those in nursing homes who don’t have family members to watch over them. More people need to speak out about this.” Sadlier transferred her mother, Rita, from a hospital to a nursing home, thinking she would get rehabilitation. Instead, her mother received poor care and even an injury. Although Rita was ... Read More

Avandia heart attack controversy results in black box warning

Avandia, a drug used in the treatment of type 2 diabetes, has been at the center of controversy since being linked to an increased risk of heart attack last May. An update to the black box warning-today’s strongest drug warning-is now being added to the Avandia label. The U.S. Food and Drug Administration (FDA) advised that GlaxoSmithKline, Avandia’s maker, agreed to add the new warning to the existing black box warning. But, despite the revision, the FDA will not withdraw Avandia from the market, claiming that evidence for increased heart attack is inconclusive and does not appear to be higher ... Read More

Gadolinium based MRI contrast agents put kidney patients at risk

Gadolinium based MRI contrast agents have been implicated in at least 1,000 cases of a debilitating disorder called Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD) around the world. This horrible disease causes a buildup of collagen in tissues, leading to a severe thickening and hardening of the skin. NSF/NSD can completely immobilize patients, and in severe cases it can lead to death. NSF/NSD is a rare disease that so far has affected only people with pre-existing kidney problems. The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000. NSF/NSD leads to excessive ... Read More

Avandia side effects prompt new caution from American Diabetes Association

Risks associated with Avandia have led the American Diabetes Association to call on doctors to use more caution when prescribing oral medications to treat people with type two diabetes. The Association announced on Tuesday that it was updating its “consensus statement” on the use of oral diabetes medications in light of the increased heart attack risks linked to some diabetes medicines, such as Avandia. Avandia’s heart attack link came to light in May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43% higher risk of having a heart ... Read More

Avandia reviewer calls for changes in FDA drug approval process

The Avandia debacle has prompted a safety official from the Food & Drug Administration (FDA) to call for changes in the way diabetes medications are approved for use in the United States. The FDA official, who reviewed the original approval application for Avandia, told the Journal of Diabetes Care that the safety and effectiveness of experimental diabetes medications should be tested against existing drugs before they are approved. If such a testing protocol were to be adopted by the FDA, it would mark a significant departure from the way most medications are granted approval in the United States. Avandia has ... Read More

Some kidney patients suffer MRI poisoning

A growing number of people are becoming afflicted with an incurable, man-made disease that is related to a common medical procedure performed every single day in this country, a KCRA 3 investigation has found. Sarah Fracella is one the victims. The 38-year-old Santa Barbara resident said what happened to her is “devastating.” The issue involves magnetic resonance imaging scans that include the use of a contrast dye containing gadolinium. For people with healthy, functioning kidneys, the risk of using the element gadolinium to pinpoint potential health problems in MRI scans is zero. “Gadolinium is extremely safe,” said neuroradiologist David Seidenwurm ... Read More

Sprint Fidelis defibrillator lead wire recall

Medtronic Inc. has had to go back to an old-reliable in the wake of last month’s Sprint Fidelis Defibrillator Lead recall. In order to continue to meet the demand for defibrillator lead wires, Medtronic has begun supplying health care providers with the Sprint Fidelis’ predecessor, the Sprint Quattro. The Sprint Quattro Defibrillator Lead is a thicker wire than the recalled Sprint Fidelis, and for some time before the recall, it was becoming apparent that the older Sprint Quattro model was safer than new Medtronic lead. Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 ... Read More