WASHINGTON (Reuters) - Novartis AG and Astellas Pharma eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in children, U.S. Food and Drug Administration staff said in documents released on Thursday.
Agency scientists said 46 cancer cases and 71 infection cases have been reported in patients aged 16 and younger from 2004 to 2008 with Novartis’ Elidel and Astellas’ Protopic.
Both drugs — also known as pimecrolimus and tacrolimus respectively — already carry strong warnings about cancer and infection, but officials should consider expanding them to include the new post-marketing reports, they wrote.
The documents were released ahead of an FDA advisory meeting Monday to weigh potential safety concerns with a variety of drugs used in younger patients.
Additionally, other FDA staffers said the warning label for GlaxoSmithKline Plc’s herpes drug Valtrex was “insufficient” for certain central nervous system side effects in children, although no other concerns were seen.
Another scientist noted concerns about the use of Pfizer Inc’s antibiotic Zmax in pregnant women and the potential for it to cause stomach blockages in newborns.
The FDA will weigh the recommendations from its panel of outside advisers before taking any action.
It was not clear what staff reviewers thought about the weight-loss drug orlistat, marketed as Glaxo’s Alli and Roche Holding AG’s Xenical. No new safety concerns were seen with other drugs to be discussed at the meeting, FDA staff said. Those drugs include:
* L’Oreal sunscreen ingredient Anthelios 40
* DuPont imaging agent Cardiolite (technetium Tc-99)
* Sanofi-Aventis allergy drug Nasacort AQ (triamcinolone); five-disease vaccine Pentacel; diphtheria, tetanus and pertussis vaccine Daptacel
* Privately held Boehringer Ingelheim’s HIV drug Viramune (nevirapine)
* Glaxo’s rotavirus vaccine Rotarix; diphtheria, tetanus and pertussis vaccine Kinrix
Editing by Dave Zimmerman