Recent document released by FDA staff that warning label for eczema drug especially for Elidel from Novartis and Protopic from Astellas should be expanded as dozen cases reported among patients under 16 years old related to cancer and infection since 2004 to 2008.

The document were released to FDA advisory meeting in Monday to get consideration for safety usage among younger patients.

According Agency scientists, 46 cancer cases and 71 cases of infection reported during certain year.
Although both drugs already have warning label about cancer and infection, however it needs expanded to including post-marketing reports.

The FDA staffers and scientist also noted related insufficient warning label for GlaxoSmithKline Plc’s herpes drug Valtrex and antibiotic Zmax from Pfizer Inc’s.

Although no other concern related to Valtrex, however FDA staffers consider due to side effects in certain central nervous system in children.

Related to antibiotic Zmac from Pfizer, scientist agency noted potential side effect of stomach blockages in newborns when those antibiotic used in pregnant women.

Drug will be concerned to review related to safety warning in the FDA advisory meeting may including;
- L’Oreal sunscreen ingredient Anthelios 40
- Glaxo’s rotavirus vaccine Rotarix; diphtheria, tetanus and pertussis vaccine Kinrix
- Sanofi-Aventis allergy drug Nasacort AQ (triamcinolone); five-disease vaccine Pentacel; diphtheria, tetanus and pertussis vaccine Daptacel
- DuPont imaging agent Cardiolite (technetium Tc-99)
- Privately held Boehringer Ingelheim’s HIV drug Viramune (nevirapine)