All Articles Tagged With: "Eli Lilly"
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.
Zyprexa Side Effects for Children Lead to Revised FDA Warnings
The FDA has required the drug maker Eli Lilly to update the warning label for their popular antipsychotic Zyprexa about potential weight-gain side effects among children.
FDA Calls Byetta, Cymbalta Claims Misleading
The FDA has warned four drug makers that they have made false and misleading statements about several different medications, including the diabetes drug Byetta, the antidepressant Cymbalta, the lymphoma treatment Treanda and the birth control implant Mirena.
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.
Zypreza, Seroquel Side Effects in Children Need Further Review: FDA Staff
According to documents released Friday, FDA staff members say that the agency needs to conduct more of an in-depth investigation into the metabolic side effects for children using Seroquel, Zyprexa and other newer atypical antipsychotics, which could lead to weight gain, diabetes and other serious health problems.
Byetta Problems Lead Public Citizen to Recommend Avoiding Use
The consumer advocacy group Public Citizen is recommending that people avoid using the diabetes drug Byetta until at least 2012, expressing concerns about potential side effects. The recommendations come the same week the FDA announced that new information will be added to the drug’s label about reports of kidney problems with Byetta, including reports [...]
Byetta Side Effects Linked to Reports of Kidney Failure: FDA Warns
The FDA announced Monday that new labeling information will be added to the diabetes drug Byetta about reports of users who developed kidney failure and other renal problems.
Zyprexa, Seroquel Use Among Kids Linked to Dramatic Weight Gain
A new study has found that use of newer atypical antipsychotics, such as Seroquel and Zyprexa, can cause rapid and dramatic weight gain among children.
