FDA Warns About Misleading Ads for Byetta, Cymbalta
The Food and Drug Administration today issued warning letters to the makers of the diabetes drug Byetta and the depression drug Cymbalta for what the agency says are false and misleading advertising practices.
The FDA said representatives of Eli Lilly and Amylin Pharmaceuticals, the companies behind Byetta, made misleading statements regarding the drug during a recent annual meeting of the Endocrine Society in Washington, D.C., in violation of federal laws for drug marketing.
“Several of these oral statements promote an unapproved use (as of the date the statements were made), broaden the drug’s indication, and overstate the efficacy of Byetta,” the FDA said. “Other statements made by the representatives exaggerate potential weight loss benefits associated with Byetta. Thus, these promotional activities misbrand the drug in violation of the Federal Food, Drug and Cosmetic Act … and FDA implementing regulations.”
Byetta Linked to Pancreas Disease
Byetta is FDA approved for use in improving glycemic control in patients with type 2 diabetes who have been unable to achieve adequate blood sugar levels. However, the use of Byetta has been linked to an increased risk of deadly pancreatic disease.
Last year, the FDA ordered stronger warnings to be added to Byetta’s packaging to address the risks of hemorrhagic pancreatitis. The warnings came after two Byetta users died and four others had to be hospitalized after suffering injuries.
Since October 2007, there have been at least 36 reported cases of acute pancreatitis in Byetta users, including some in which patients died.
Cymbalta Warning Also Issued
The FDA also has warned Eli Lilly about print ads the company circulated directly to consumers for Cymbalta.
“The print ad is false or misleading in that it presents efficacy claims for Cymbalta, but fails to adequately communicate the risks associated with its use,” the FDA said. “The Blue Book Message is false or misleading because it overstates the efficacy of Cymbalta and minimizes the risks associated with the drug.”
Cymbalta is also commonly prescribed for patients suffering from the chronic pain disorder fibromyalgia.
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SHAME ON YOU…for attempting to discredit a company that is actually saving the lives of diabetes patients. This drug is neither dangerous nor the cause of the metioned pancreatitis — as evidenced by the data provided in clinical studies. Also reported — diabetics have a high incidence of pancreatitis on their own, without Byetta. That these patients with pancreatic issues happened to be on Byetta is coincidental. And, further probing the deaths, you will also find that some of the patients actually died from non related conditions such as surgery, lukemia etc.
This drug safely reduces the A1C levels of patients, controls their glucose and even helds to repair their beta cells. It is saving the life of hundreds of thousands of patients.
How do you sleep at night?
Nathan, sounds like your real beef is with the Food and Drug Administration, which issued the warning letters about Byetta and the other drugs. However, since you decided to blame the messenger here, I’ll say that if the pancreatitis in Byetta users is simply coincidental as you claim, the emerging medical research on this topic is not finding so.
Thanks for reading.