Quoted from http://www.businessweek.com/ap/financialnews/D9GPM8QO0.htm
Cornerstone gets FDA warning on Zyflo CR marketingNEW YORK
The Food and Drug Administration said Tuesday it sent a warning letter to Cornerstone Therapeutics Inc. alleging that Cornerstone's promotional materials withheld information about the risks of its asthma drug Zyflo CR.
The FDA said the materials violated the Food, Drug, and Cosmetic Act. Some of the materials used outdated labeling and suggested Zyflo CR is more effective than competing drugs like Singulair, according to the FDA's letter. The FDA contacted Cornerstone on June 22 and the company's website appears to contain updated information about the drug.
According to the FDA, a Cornerstone web page about Zyflo CR presented claims about the drug's effectiveness, but left out information about its risks, which can include liver toxicity and neuropsychiatric events like sleep disorders and behavioral changes. The page also left out information stating that Zyflo CR is not recommended for people with liver disease, or who have allergic reaction to ingredients.
The agency also said a Cornerstone visual aid did not include warnings about the most serious side effects or the most common ones. While the aid included some information about the drug's risks, that information was printed on the back of the visual aid. But the item had an adhesive strip on the back, so the information would not have remained visible.