Pharmaceutical 7430 articles

Recalled heart implant gives man shock of his life

In early December, Jerry Jackson received the shock of his life. Or six. The 63-year-old Mineola resident was sweeping crumbs off the bed where his granddaughter sat when a sudden surge in his chest caused him to twist in agony. His implanted cardiac defibrillator (ICD) had sent 800 volts of electricity into his heart muscle, a jolt doctors compare to being kicked by a horse. Then it did it again. And again. “I was hollering every time it hit me,” Jackson said. “It hit me six times … it’s a good wallop. I began to think it wasn’t going to ... Read More

Avandia starting to sound a lot like Vioxx

Mark D. is fighting for justice on behalf of his brother, Grant, whose health has gone downhill since he was prescribed Avandia. Grant started taking Avandia two years ago after he was diagnosed with type 2 diabetes. Prior to taking Avandia, he had no history of heart problems. “Grant had never had any problems in the past,” Mark says. “He had a clean bill of health in terms of his heart prior to that. There was no history of heart disease in our family.” Within a year of being on Avandia, Grant was diagnosed with high blood pressure. Within two ... 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

Sprint Fidelis defibrillator lead patients faced with difficult dilemma

Many patients implanted with defective Medtronic Sprint Fidelis Defibrillator Leads have found themselves in a medical limbo. If they are fortunate enough not to have already experienced a lead fracture, they must decide between two difficult choices, leave the Sprint Fidelis lead alone and hope it won’t fracture; or undergo a difficult and dangerous surgery to have the faulty lead replaced. Both options are bad ones, a fact that has left many Sprint Fidelis Lead patients anxious and confused. Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is ... 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

Medtronic dfibrillator cass ation lawsuit gets go ahead in Canada

Medtronic Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead Wire, is now facing a lawsuit filed by a group of Canadians who claim the company failed to warn consumers of a defect in the batteries installed in its defibrillators. Last week, Ontario Superior Court Judge Alexandra Hoy certified the class-action lawsuit in a ruling released Dec. 6 in Toronto, allowing the plaintiffs to seek a portion of Medtronic profits for damages. In Canada, 2,416 patients had the Medtronic defibrillators implanted as of February 2005, with 613 of them having been removed or replaced as of June 2007. In ... 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