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Deceptive, Says FDA of Ads by Sunovion to Support Its Respiratory Drug Brovana

Filed November 1st, 2013 Laurie

The U.S. Food and Drug Administration (FDA) said in a letter released October 24 that Sunovion Pharmaceuticals Inc. deceptively marketed its respiratory drug Brovana by burying the risks in fine print and exaggerating its effectiveness by claiming the drug would completely revitalize patients.

Sunovion asserted that Brovana might help patients “get back to daily living.” The drug is used to treat chronic obstructive pulmonary disease, or COPD.

The FDA said that, in reality, clinical trials showed that Brovana produced a roughly 10 percent improvement in the volume of air patients can exhale during a forced breath. According to Law360, the FDA wrote that there is no evidence that Brovana’s benefits, coupled with its side effects, will result in an “overall positive impact on patients’ ability to resume their baseline activities of daily living.” The FDA’s letter called for a halt to Sunovion’s deceptive marketing practices and an explanation of how the drug maker will respond to the letter.

The FDA also noted in its letter that it took issue with several statements that created the unsupported impression that Brovana is superior to rival drugs. The letter concluded that Sunovion’s attempts to hide Brovana’s risks – including a Black Box Warning of related fatalities involving patients with asthma, as well as chest pain and sinusitis – undermined the conveyance of important risk information, “minimizing the risks associated with Brovana.”

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