FDA warns Forest Labs about hypertension drug ad

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Forest Labs claimed superiority of its hypertension drug without proof. Image Source: Natural Cures  

The FDA has sent a warning letter to Forest Laboratories for promoting its Bystolic high blood pressure drug to physicians without properly noting its potential risks.

An eight-page ad, which ran in various medical journals, also implied Bystolic (nebivolol) is superior to its rivals, even though there is no substantial evidence to prove such claims.

“The journal ad makes unsubstantiated superiority and mechanism of action claims, omits and minimizes risks associated with the use of Bystolic, and makes unsubstantiated efficacy claims for the drug,” Thomas Abrams, RPh, the FDA’s director of drug, marketing, advertising and communications, wrote in the warning letter.

He said that as a result of the advertisement, the New York City-based Forest was in violations of several codes under the Federal Food, Drug and Cosmetic Act. Abrams added that the ad is also “concerning from a public health perspective because they suggest that Bystolic is safer and more effective than has been demonstrated by substantial evidence.”
“Although the journal ad does include important safety information on its second page, it omits and minimizes certain risks associated with Bystolic therapy, thereby implying that Bystolic is safer than other ß-adrenergic receptor blocking agents,” Abrams said.

Frank Perier, senior vice president for finance and chief financial officer told Reuters that the ad had appeared in a variety of professional medical journals since January, but was no longer in use.