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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

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

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

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

Did Medtronic act quickly enough on recall

Medtronic issued the recall of leads in October, amid mounting evidence that a small percentage of the leads were fracturing. Those fractures caused some patients to receive unneccessary shocks from their defibrillators, while other patients did not receive a lifesaving shock when they had a slow heart rhythm. The lead failures may have contributed to five deaths. At the time of the recall, Medtronic took great pains to underscore that the Fidelis leads had a 2.3 percent failure rate after 30 months of implantation. That compared to a 1 percent failure rate among the company’s Quattro leads, which have been ... Read More