Brovana Claims Misleading, Side Effects Minimized: FDA Warning Letter

The FDA has issued a warning letter to Sunovion Pharmaceuticals, indicating that claims the drug manufacturer made about its respiratory drug Brovana are misleading and fail to adequately disclose the potential side effects. 

Brovana brochures and marketing materials make unsubtantiated claims about the medication, according to an FDA warning letter issued October 24.

The FDA accuses the company of claiming that Brovana can make users with breathing problems resume living a normal life and that it is more effective than other treatments, both of which the agency has indicated are misleading characterizations.

Brovana (arformoterol tartrate) is a bronchodilator. It is an inhaled solution used to treat patients with chronic obstructive pulmonary disease (COPD) who may also suffer from chronic bronchitis and emphysema. It works by relaxing muscles in the airways to improve breathing.

The FDA warning lists several grievances against the Massachusetts-based company over violations of the Federal Food, Drug, and Cosmetic Act. The claims Sunovion made about Brovana seriously “misbrand” the drug, according to the FDA.

“These claims misleadingly overstate the efficacy of Brovana by suggesting that an outcome of treatment with Brovana is the ability for patients to resume their baseline activities of daily living,” the warning letter stated.

The FDA also said the Brovana brochures include claims of superiority over other drugs used to treat COPD. The brochures suggest that the drug is more effective than other medications, but this claim has not been backed up with clinical evidence to support it.

Sunovion also uses a tagline, “Get back into daily living,” in marketing materials, which the FDA criticizes in the warning letter, noting it overstates the efficacy of the drug.

Clinical studies for Brovana reveal treatment with the drug may cause an 11% improvement in breathing for people suffering from COPD. The FDA argues that improvement in no way represents a dramatic change in lifestyle, like the tagline implicates. To say the drugs is safer or more effective than another drug is deceptive and has not been proven, warns the FDA.

“We are not aware of any adequate and well-controlled head-to-head studies supporting the implication that Brovana is clinically superior to other COPD therapies,” the FDA stated.

In addition, the advertising materials minimize the potential side effects of Brovana, with risk information placed in a single spaced, small font; as opposed to the large-type bold-faced lettering for the tag lines.

Potential for Brovana risks include chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheral edema and lung disorder.

Brovana also contains a Boxed Warning, which warns patients against asthma related complications, as Brovana has not been approved for use in patients who also suffer from asthma.

The FDA warns Sunovion to stop using the promotional materials in question. Federal officials also request a written response by Nov. 7 indicating whether the company will comply and change the marketing materials accordingly.