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FDA Puts Black Box Warning on Arzerra and Rituxan, Drugs for Blood Cancer Treatment

Filed September 26th, 2013 Joshua Sophy

People who’ve been previous infected with the hepatitis B virus who may be taking two blood cancer drugs face a risk of reviving the infection. This can lead to life-threatening side effects and has prompted a stronger warning on the drugs from federal health regulators.

According to a Reuters report this week, the U.S. Food and Drug Administration (FDA) has boosted its warning on the drugs Arzerra and Rituxan. Arzerra is approved to treat chronic lymphocytic leukemia. Rituxan is most often prescribed in the treatment of the same condition, as well as non-Hodgkin’s lymphoma, and rheumatoid arthritis.

The FDA will place its strongest warning, a Black Box warning, on safety labels of these two drugs – and their generics – to indicate this risk. The warning will note that several new reports of death among patients taking these drugs led to the Black Box warning. The warning only applies to patients taking either Rituxan or Arzerra who have been previously infected with hepatitis B. Taking either of these cancer drugs can “reactivate” the infection and potentially lead to death, Reuters notes. Hepatitis B is an infection of the kidneys and the condition can cause serious liver damage, result in liver failure, and potentially death.

Physicians who are considering prescribing either of these two drugs for new patients should screen them for prior hepatitis B infections, the FDA also warns. If a patient is already taking these drugs and has been previously infected with hepatitis B, the physician should also note any potential signs of that infection resurfacing, according to Reuters.

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