FDA ISSUES UNTITLED LETTER FOR SCHERING TO CEASE FORADIL PROMOTION

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued an untitled letter to Schering informing the company of misleading information it published recently in a professional detail aid promoting the use of Foradil Aerolizer 12 mcg.

The detail aid failed to disclose warnings and information about possible adverse reactions that are included in the indications and usage section of Foradil's (formoterol fumarate inhalation powder) approved product labeling. For example, the detail aid claimed Foradil can be used "for your patients with chronic obstructive pulmonary disease, asthma, or exercise-induced bronchospasm."

However, DDMAC stated in its letter, the indications section of the product labeling says that Foradil "is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta-2 agonists." Therefore, DDMAC said Schering's presentation in the detail aid "improperly suggests that Foradil can be used for any type or severity of asthma."

DDMAC asked Schering to immediately cease the dissemination of the detail aid and any other promotional materials that make similar claims. A Schering spokeswoman said the company has ceased distribution of the promotional materials. Schering has also contacted employees in the field that may still have the promotional item and has asked that they be sent back to the company so they can be destroyed, she said.

To view the untitled letter, go to http://www.fda.gov/cder/warn/2004/Foradil_FINAL%20DFS%20letter21.pdf (http://www.fda.gov/cder/warn/2004/Foradil_FINAL%20DFS%20letter21.pdf).