Forest Laboratories Inc was sent a warning letter (dated 8/28/08) by the Food and Drug Administration in relation to misleading advertising of the drug Bystolic. The two main arguments made by the FDA are that the advertising used “Unsubstantiated Superiority and Mechanism of Action Claims” and that there was “Omission and Minimization of Risk” about Bystolic and “Unsubstantiated Efficacy Claims” .

According to the letter, the advertisement omitted precautions regarding the interaction between Bystolic and 2D6 inhibitors, and did not adequately warn individuals with congestive heart failure. The FDA also notes that certain phrases in the ad imply that Bystolic is superior to certain other drugs against which it has not been adequately tested. Finally, even though clinical trials were not intended to prove such an effect, the advertisement apparently claimed that Bystolic worked better in patients who are obese, diabetic or have poor metabolism.