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.
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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.
BarryMay 29, 2016 at 11:38 pm
I've been doing the brovana over a year and as a result I do not see much change I cannot still walk a hundred yards but yet I can pass a stress test I had 2 heart attacks in the same weekend October 9th & 10th 2015 I don't know if the drug has something to do with it but now I live with a stent I have to take blood thinners I had 3 herniated disc I can't do anything about because of the blood thi[Show More]I've been doing the brovana over a year and as a result I do not see much change I cannot still walk a hundred yards but yet I can pass a stress test I had 2 heart attacks in the same weekend October 9th & 10th 2015 I don't know if the drug has something to do with it but now I live with a stent I have to take blood thinners I had 3 herniated disc I can't do anything about because of the blood thinners this drug had something to do with me having all the chest pains I did and the serious problem I had when I went in the hospital whatever it is it needs to be on it to see if that was the cause of this I believe that all medical manufacturers of drugs put out to the public should have a little bit more consideration for the lives of the people instead of stamping false statements hiding important statements that can cost people their lives or their way of life therefore I'm stating did Pravana has something to do with me having a stent in me with an n in the whole thing with the surgeries I can't have my surgeries or nothing and the pain and suffering I'm going through with this Lookout I will hire a really good attorney. May God forgive the actions of the person that knows about this before it hits the markets.
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