Respiratory Drug Brovana Misleading Material. Parker Waichman LLP is investigating a potential class action lawsuit on behalf of patients who took Sunovion, a respiratory drug that federal health officials charge was promoted to the public with misleading material.
Marlborough, Mass.-based Sunovion Pharmaceuticals Inc., a unit of Osaka, Japan-based Dainippon Sumitomo Pharma Co. Ltd., received approval for its respiratory drug Brovana (generic name: arformoterol tartrate) by the U.S. Food and Drug Administration (FDA) on Oct. 6, 2006. Described as an “inhalation solution,” Brovana was approved for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Meant for long-term, twice daily (mornings and evenings) use, the drug is ingested via a nebulizer only.
The drug was not approved to treat acute deteriorations resulting from COPD; nor was it meant to serve as a treatment for asthma.
From the onset, the drug posed serious risks. The FDA-approved product labeling included a black-boxed warning regarding asthma-related deaths as well as contraindications in patients who have a history of hypersensitivity to arformoterol, racemic formoterol, or to any other components of Brovana, as well as in patients with asthma without the use of a long-term asthma control medication. The label also had warnings and precautions, including deterioration of disease and acute episodes, excessive use of Brovana and use with other Long-Acting Beta-Agonists (LABA), among other things.
The most common adverse reactions associated with Brovana during clinical trials were pain, chest pain, back pain, diarrhea, sinusitis, leg cramps, dyspnea, rash, flu syndrome, peripheraledema, and lung disorder.
FDA’s Letter to Sunovion Outlines Concerns Based on ‘Misleading’ Patient Brochures
The FDA charged in a letter sent to Sunovion on Oct. 24, 2013, that patient brochures made by the drug maker to support Brovana were “are misleading” for several reasons, including:
- They overstate the drug’s efficacy
- Make unsubstantiated claims, including unsubstantiated superiority claims
- Minimize risks associated with the drug
The FDA noted in its letter to Sunovion that it believed the drug maker was attempting to promote Brovana in a deceptive manner, burying in fine print all references to the drug’s risks, which are numerous and include the black-box warning of potential fatalities for asthma patients, while highlighting in big, bold fonts the drug’s supposed benefits. The brochures also exaggerate the drug’s effectiveness by claiming it could help patients “resume their baseline activities of daily living.” Such claims were precluded by results of clinical studies, which found that Brovana produced an improvement of about 10 percent in the volume of air patients can exhale during a forced breath. Overstatement of that benefit, however, when weighed against the dangers of the drug’s side effects, created a false impression, the FDA said.
Legal Help for Patients Misled by Respiratory Drug Brovana
If you or a loved one took the prescription drug Brovana, you may have valuable legal rights. To find out more about joining a Brovana class action lawsuit, please fill out our online form or contact one of our experienced product liability lawyers today at 1(800)-YOURLAWYER (1-800-968-7529).