Latest News

Two U.S. healthcare providers drop Glaxo’s Avandia

Two U.S. pharmacy benefit managers said on Thursday they had dropped GlaxoSmithKline Plc’s (GSK.L: Quote, Profile, Research) diabetes drug Avandia from their national formularies due to safety concerns. The moves by Prime Therapeutics and HealthTrans mark the latest example of U.S. healthcare providers deciding to limit access to the drug, following an earlier decision by the U.S. Department of Veterans Affairs to severely restrict use. Such actions, particularly if followed by others, may further undermine sales of the once-popular medicine, which have been hit hard recently by a report linking it to heart attacks. Prime and HealthTrans said in separate ... Read More

High court may bar claims for FDA-approved drugs

The U.S. Supreme Court will hear arguments today in the first of two cases this term that consumer advocates fear could shut courthouse doors to patients injured by FDA-approved drugs or medical devices. Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices. The case before the court today was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. ... Read More

Medtronic asks Supreme Court to ban personal injury lawsuits

Medtronic, Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead and several other defective medical devices, will try to convince the US Supreme Court that people injured by dangerous medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration (FDA). If Medtronic is successful, the thousands of people injured by the company’s defective devices, as well as those hurt by faulty drugs and devices made by other manufacturers, would not be able to receive compensation for their injuries in state courts. The Medtronic Supreme Court case ... Read More

Avandia now linked to Osteoporosis

GlaxoSmithKline, the manufacturer of Avandia, has already admitted that Avandia does contribute to bone fractures in women. However, the latest research goes further in understanding the issue, just what is happening to those brittle bones, and what it is that’s making them brittle in the first place. Initially, it was thought that rosiglitazone, the generic term for the drug that is marketed as Avandia, was serving as a governor to the bone-building process. In other words, as bones evolve in the human body (much like skin), it was originally thought that Avandia somehow contributed towards an inability to effectively regenerate ... Read More

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