U.S FDA strengthens warnings on Glaxo, Roche/Biogen cancer drugs

Sept 25 Wed Sep 25, 2013 11:33am EDT

Sept 25 (Reuters) - U.S. regulators strengthened the warning labels on two cancer drugs - GlaxoSmithKline Plc's Arzerra, and Rituxan, made by Biogen Idec Inc and Roche Holding AG - to reflect the risk that they can reactivate the hepatitis B virus in patients previously infected with it.

The U.S. Food and Drug Administration said the risk is already described in the warnings and precautions section of the label for both drugs. Now the information will be placed in a black box, indicating the most serious type of risk.

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.