FDA Calls Byetta, Cymbalta Claims Misleading
Published: January 14th, 2010 • One Comment
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.
The FDA letters were sent to Amylin Pharmaceuticals, Eli Lilly and Co., Bayer Healthcare Pharmaceuticals and Cephalon, alerting the companies that federal regulators were aware of statements made by representatives that provided misleading or false information about the benefits of their products. In some cases, the companies also promoted their drugs for uses not approved by the FDA.
In a letter to Amylin Pharmaceuticals regarding Byetta (exenatide) , the agency said that representatives speaking at the Endocrine Society’s Annual Meeting (ENDO) in June promoted the drug for off-label uses, saying that it could be used as a stand-alone diabetes treatment, when Byetta was only approved at the time for use with other diabetes medications. Since that time, Byetta has been approved for solo use. The letter also says that representatives exaggerated the potential weight loss benefits of Byetta, and overstated its efficacy.
Byetta is a type 2 diabetes drug that is used to control blood sugar levels. It is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels.
The letter is just the latest problem for the drug maker. In November, the FDA issued a new warning indicating that they have received at least 78 post-marketing reports that link Byetta side effects to kidney problems, including 62 cases where the users experienced kidney failure. And in October 2007 and August 2008, the FDA issued safety alerts about reports of Byetta pancreatitis problems, including severe cases of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal. Symptoms of pancreatitis, which is an inflammation of the pancreas, include nausea, vomiting, severe pain in the upper abdomen and back, a rise or fall in blood pressure, and increased heart or respiratory rates.
The FDA letter to Eli Lilly was sent over their antipsychotic Cymbalta (duloxeitine hydrochloride), citing the company for direct-to-consumer print advertisements that made false or misleading claims about the drug’s effectiveness while failing to note any Cymbalta health risks in the main ad. The health risk information was on an adjacent page in a way that appeared unconnected to the main advertisement, FDA regulators noted.
The warning letter regarding Bayer’s contraceptive intrauterine device (IUD) Mirena (levonorgestrel) claims that the company overstated the drug’s effectiveness, made unsubstantiated claims and minimized the risks in a live consumer-directed program, where representatives travel to consumers’ homes.
Bayer has run into trouble in the past with the FDA over marketing claims involving its contraceptive products. In late 2008, the FDA and several state attorney generals forced Bayer to run a $20 million corrective advertising campaign for its Yaz birth control pills because prior marketing contained false claims about the drug’s acne and PMS-fighting benefits, and did not clearly state all of the known Yaz side effects, drowning some of them out with loud music. As a result of the misleading advertisements, Bayer agreed that the FDA will screen future Yaz ads for six years before they can be aired.
A fourth letter targeted at Cephalon’s leukemia medication Treanda (bendamustine hydrochloride), citing problems with pocket dosing cards that omit information on Treanda health risks and dosing information.
All of the companies have been warned to immediately cease any false or misleading advertisements and have been ordered to explain whether they intend to comply with the request and how or why they believe the false and misleading drug advertisement claims are incorrect.
Comment by cassandra on 3 March 2010:
i was on the mirena iud after my youngest was born in july 2007. we had it removed about 9 months later due to how uncomefertable it was. in june of 2009 we desided to try again for baby three. we were sussful but lost the baby in oct. doc wanted us to wait a full cycle to try again. we were praganet by dec. and lost the baby in jan 2010. im hearing rumors of a recall about a recall due top infertilty and loss of a pragancys????? if this is true i would like more info on the subject plz.