All Articles Tagged With: "Amylin"

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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. 

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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. 

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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.

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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.

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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.

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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 [...]

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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.

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FDA Warning of Byetta Pancreatitis Side Effects Contradicted by New Studies

New research suggests that there may not be a correlation between the diabetes drug Byetta and acute pancreatitis, raising questions about whether the drug caused prior reports of severe necrotizing pancreatitis and hemorrhagic pancreatitis that prompted an FDA warning last year.

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Byetta Thyroid Cancer Risk Not Seen According to Amylin

According to Amylin Pharmaceuticals, Inc., the new long-acting version of their diabetes drug Byetta does not have the same link to thyroid cancer recently associated with Novo Nordisk’s Liraglutide, a similar diabetes drug in the same class of medications that the FDA is also considering for approval.

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Amylin Says Byetta Side Effects Not Linked to Risk of Heart Problems

Amylin Pharmaceuticals, Inc. and Eli Lilly and Co. said this week that a new meta-analysis of clinical data for their diabetes drug Byetta indicates that the injection does not increase the risk of cardiovascular events. The drug makers will use the data to support a new once-weekly version of the medication amid closer scrutiny by [...]