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FDA sends warning letter to asthma drug maker

According to Business Week, the Food and Drug Administration (“FDA”) announced earlier this week that it has sent a warning letter to drugmaker Cornerstone Therapeutics Inc. The product liability warning letter alleges that the company’s promotional materials withheld information about the risks of its asthma drug Zyflo CR. The FDA also reported that the materials violated the Food, Drug, and Cosmetic Act; some of the materials used outdated labeling and suggested that Zyflo CR is more effective than competing drugs like Singulair. Since the FDA contacted Cornerstone on June 22, the company website appears to contain updated drug information.

According to the FDA, the drugmaker left out significant information about Zyflo CR’s risks, which include liver toxicity and neuropsychiatric events. It also neglected to disclose that the asthma drug is not recommended for people with liver disease or who have allergic reactions to ingredients.

Issues with drug companies like this often fall in the realm of products liability, which is an area of personal injury law that focuses on dangerous and defective products. The Chicago product liability firm of Levin & Perconti has represented numerous plaintiffs in Illinois in matters against manufacturers who have sold or manufactured unsafe products to consumers.

For more information about the FDA product warning letter, click on the link.