Product News and Recalls

FDA Claims Manufacturer Withheld Info

According to U.S. Food and Drug Administration documents, the manufacturer of diabetes drug Byetta tried to conceal from federal regulators a study that linked the drug to potential heart problems.

In large part because of Amylin Pharmaceuticals’ deceitfulness, The Street reports, the FDA rejected another diabetes drug the company submitted for approval. And Amylin Pharmaceuticals subsequently misled investors about the reason for that rejection.

According to The Street, Amylin has been selling Byetta since 2005.

The drug has since generated some safety concerns. Studies have linked Byetta and another diabetes drug, Januvia, to pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

The Street says Byetta is inconvenient because diabetics have to inject themselves twice per day. Amylin developed and sought approval for Bydureon, which uses the same drug ingredient as Byetta but requires only one injection per week.

When the company submitted Bydureon to the FDA for approval, the company tried to conceal an earlier study that “raised significant heart safety concerns,” The Street reports. The FDA later cited that as a reason for the drug’s rejection.

During a 2010 conference call with analysts and investors, Amylin CEO Dan Bradbury presented the FDA’s rejection of Bydureon as a surprise to the company and said nothing about the concealed study.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.

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