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Food and Drug Administration 233 articles

Recalled product inserted in patient

After suffering months of excruciating pain following surgery, a Virginia Beach, Va., woman learned yesterday that a recalled mesh patch had been used by the hospital where she underwent a hernia operation nearly a year ago. The Kugel Mesh patch, made by Davol Incorporated, was recalled by the FDA because it breaks up after insertion in patients, which can result in serious injury. A report on WAVY TV-10 in Virgina Beach said the hospital initially denied using the recalled product on the patient, Judith Coyne. But Coyne and her son, who uncovered the mesh patch recall alert while researching possible ... Read More

FAA Bans Chantix

The Wall Street Journal reported in its Health Blog on May 21 that the Federal Aviation Administration has banned the stop-smoking drug Chantix for pilots and air traffic controllers. According to the report, Pfizer’s smoking-cessation drug Chantix came in for a bit more trouble as a research group cited reports of physical side effects associated with the drug. The FAA, which reviewed the report, barred pilots and air traffic controllers from taking the drug, the WSJ reports. The Institute for Safe Medication Practices examined adverse-event reports turned into the FDA in the fourth quarter of last year, and found 988 ... 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

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

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

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

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