Baxter International has been issued a warning by the U.S. Food and Drug Administration (FDA), for misleading patients and doctors about the benefits of its Aralast NP drug.
In an Aug. 3rd warning letter, the FDA said the company brochure made misleading efficacy claims about the drug, which is used to treat emphysema patients with a specific genetic abnormality.
The FDA’s letter notes Baxter has been warned about similar violations in April 2009 and July 2008. Because of this, the FDA also asked Baxter to explain in writing the policies and procedures it plans to adopt to ensure its prescription drug promotional activities comply with the Federal Food, Drug and Cosmetic Act, writes WSJ.
In response to the warning, Baxter released a statement that they would put the brochure on hold.
A wide mix of medical staples used in hospitals — including blood plasma, kidney dialysis treatments and cancer drugs are made by Baxter.