New drug warnings poised for rollout

New warnings and warning recommendations are flying out of the FDA this week like geese flying south for the winter, partly because of an FDA advisory panel is meeting. Here's the latest:

  • Committee members want a stronger warning against using Cephalon's Provigil drug in children. Used to treat sleep disorders in adults, the drug sometimes is used off-label in for ADHD in kids. Panelists want doctors to know Provigil shouldn't be used in children. Just recently, Provigil's label got a new warning of serious skin reactions and psychological problems.
  • Novartis added a new warning of birth defects to its organ-rejection treatment Myfortic. The FDA says women who are planning to get pregnant should only use Myfortic if they have no other options.
  • The FDA's pediatric committee voted for stronger warnings of psychiatric side effects on both Roche's Tamiflu and GlaxoSmithKline's Relenza. Roche already agreed to the warning, though it admits no causal relationship between its drug and the side effects; so far, Glaxo has only blamed the side effects on the flu itself.
  • Glaxo's Serevent and Advair also got hit with recommendations for more specific warnings on the risk of asthma-related complications in children. Glaxo says it thinks the current black-box warning is sufficient, even though it doesn't specifically mention kids. The FDA also says it plans a new safety review of the drugs.

- read The Motley Fool report on Myfortic
- see the Provigil article from the Associated Press
- read the latest on Tamiflu and Relenza from the Philadelphia Business Journal
- here's more on GSK's asthma drugs