FDA warns maker of asthma drug Zyflo CR of legal violations in marketing materials
The U.S. Food and Drug Administration (FDA) has issued a warning letter to the maker of an asthma drug for marketing materials that inflated the drug’s benefits while not reporting some of its risks.
The June 22 letter to drug maker Cornerstone Therapeutics Inc. stated that the company’s web page about Zyflo CR failed to provide information about the drug’s risks, such as liver toxicity, sleep disorders, and behavioral changes, or that the drug is not recommended for patients with liver disease or a history of allergic reactions to the ingredients.
