Two Cancer Drugs Receive Black Box Warnings
The U.S. Food and Drug Administraion will now require two cancer drugs to contain a black box warning for hepatitis B risks.
Drugs Affected by the New Black Box Warning Requirement
- According to Reuters, the black box warning will be required on two drugs used to treat chronic lymphocytic leukemia (CLL).
- The first is GlaxoSmithKline’s Arzerra. The drug was approved for treatment of CLL in 2009 and is prescribed to patients who did not see improvement while using other cancer medications.
- The other, Rituxan, was developed by Roche and Biogen and is also used to treat non-Hodgkin’s Lymphoma and rheumatoid arthritis.
Black Box Warning Address Hepatitis B
- The FDA states that though the risks are already described on labels, cases of reactivation have persisted and some patients have died.
- Physicians are recommended to screen all patients for hepatitis B before prescribing the drugs, and to monitor patients with prior hepatitis B infections.
- Like hepatitis C, hepatitis B is a chronic disease that infects the liver causing swelling and inflation eventually leading to liver failure.
- As the drugs work by suppressing the immune system, patients’ bodies become less adept at fighting hepatitis B infections.
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