FDA Puts Black Box Warning on Two Drugs


The U.S. Food and Drug Administration last week indicated that it has strengthened the warnings on a pair of blood cancer drugs because of an increased problem with hepatitis B reactivation.

The drugs in question are:

  • Arzerra: FDA approved in 2009 for the treatment of chronic lymphocytic leukemia (CLL).
  • Rituxan: FDA approved in 1999, and currently an approved treatment for CLL and non-Hodgkin's follicular lymphoma, among other diseases.

Heightened risk of hepatitis B

The FDA will add a black box warning to the drugs, illuminating the already-known risk that these drugs can cause reactivation of the hepatitis B virus in any person previously infected with it. Despite the fact that the warning is included in the label, patients with a history of hepatitis infection are being given the drug and some have died on account of it.

Doctors are being strongly urged to screen all patients for hepatitis B infection prior to administering or prescribing either drug, as both will suppress the immune system and make the body vulnerable to reactivation, illness and possibly death.

Source: FDA

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