Eczema creams may require expanded warnings

April 6, 2010

Washington - The Food and Drug Administration says Novartis AG and Astellas Pharma may need to expand warning labels on their eczema drugs following dozens of new reported cases of cancer and infection in children, Reuters reports.

Washington - The Food and Drug Administration (FDA) says Novartis AG and Astellas Pharma may need to expand warning labels on their eczema drugs following dozens of new reported cases of cancer and infection in children, Reuters reports.

In documents released last month, FDA scientists said 46 cancer cases and 71 infection cases have been reported in patients age 16 and younger who were treated with Novartis’ Elidel (pimecrolimus 1 percent) and Astellas’ Protopic (tacrolimus) from 2004 to 2008.

Both drugs already carry strong warnings about cancer and infection. The FDA documents stress, however, that both companies should consider expanding the labels to include the new post-marketing reports.