All Articles Tagged With: "Kidney Failure"
Articles
FDA Rejects New Byetta Formula, Questions Health Risks and Manufacturing
The FDA has denied approval for a once-weekly version of Eli Lilly’s and Amylin Pharmaceuticals’ diabetes drug Byetta, saying that the agency needs answers to certain questions about the drug makers’ manufacturing processes and how it intends to mitigate Byetta health risks to users.
Problems with Byetta Production Plant Identified by FDA
FDA inspectors have identified a number of quality control and training issues at Amylin Pharmaceutical’s Byetta manufacturing plant in Ohio, just as the agency prepares to decide whether to approve a new formulation of the diabetes drug and concerns mount about potentially serious side effects of Byetta.
Baxter HomeChoice Dialysis Machine Recall Issued After Reported Death
The FDA has issued a Class 1 recall for several models of Baxter HomeChoice automated dialysis systems because of a defect that can cause the machines to overfill a patient’s abdominal cavity with fluid. Reports of at least one death and several serious injuries have been associated with the problems.
Black Box Warning Added About Side Effects of Exjade
The FDA has announced that it is requiring a new “black box” warning to alert patients to the potential dangers of Exjade side effects, an iron-reducing medication made by Novartis AG, which could increase the risk of kidney problems, liver problems and gastrointestinal bleeding.
E. coli Lawsuit Filed Over Tainted Meat That Sickened People in 16 States
An E. coli poisoning lawsuit has been filed on behalf of a 14-year-old boy who was hospitalized after eating tainted beef that was part of a recent nationwide meat recall that has caused at least 21 cases of food poisoning in 16 different states.
E. Coli O157:H7 Ground Beef Recall Issued for 864,000 Pounds of Meat
Nearly 900,000 pounds of ground beef and other beef products distributed by Huntington Meat Packing Inc. have been recalled due to the risk of illness from E. coli contamination.
Fleet Phospho-Soda Settlement Being Negotiated
Plaintiffs in more than 1,200 Fleet Phospho-Soda lawsuits have until next week to submit information about their claim to lawyers who are negotiating a global settlement for the cases, which involve allegations that the over-the-counter colonoscopy prep caused consumers to suffer kidney damage and other injuries.
Lawsuit Alleges Byetta Caused Fatal Liver and Pancreatic Cancer
A lawsuit has been filed against Eli Lilly & Co. and Amylin Pharmaceuticals by a woman who says side effects of Byetta caused her husbands death from liver and pancreatic cancer.
Byetta Pancreatitis Risk Needs Further Studies: FDA
The FDA has required the makers of the diabetes drug Byetta to conduct additional studies to clarify the risk of pancreatitis from side effects of their medication.
Fleet Phospho Soda Lawsuits in MDL to be Trial Ready by Oct. 2010
The first Fleet Phospho-soda trials in the federal MDL, involving claims of kidney damage caused by use of the recalled laxative during colonoscopy prep, could start as early as October 2010.
