The FDA gives Arzerra a black box warning.
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Arzerra Hepatitis B Injury Lawsuit

The U.S. Food and Drug Administration (FDA) has warned the public that the immune-suppressing and anti-cancer drug ofatumumab—sold under the brand name Arzerra—might reactivate hepatitis B infections.

What Is Arzerra? When Is It Prescribed?

Arzerra is the brand name for the drug ofatumumab. Made and sold by British pharmaceutical giant GlaxoSmithKline plc, this medication is prescribed to treat chronic lymphocytic leukemia (CLL). The FDA approved the drug in October 2009 in the form of an intravenous injectable.

CLL is the most common type of leukemia, and it occurs when B-cell lymphocytes grow out of control in the bone marrow and blood stream. B-cell lymphocytes contain an antigen called B-lymphocyte antigen CD20 (CD20), whose purpose is optimizing B-cell lymphocytes’ ability to attack infections. Arzerra is a monoclonal antibody that binds to CD20 and in the process kills the cancerous B-cell lymphocyte.

Arzerra Might Reactivate Hepatitis B Infections

On September 25, 2013, the FDA issued a drug safety communication warning the public that it had mandated changes to Arzerra’s label to include a black box warning, the agency’s most serious kind of alert. The communication also applied to Rituxan, a similar drug to Arzerra. The new label prominently displays information about the possibility that Arzerra can cause the hepatitis B virus to reactivate in users who either had hepatitis B or are carriers for the virus. It is also possible for patients who were never infected with hepatitis B to contract it as well. Adverse side effects of hepatitis B reactivation can include:

  • Fulminant hepatitis (acute liver failure)
  • Hepatic failure
  • Death

The agency based its decision to issue the drug safety communication on data collected from its Adverse Event Reporting System database for the time period from October 2009 and August 2012. The FDA identified three cases of fatal hepatitis B-related acute liver injuries in Arzerra users. Another 106 Rituxan users died from the same causes, but that drug has been on the market longer.

The FDA advises health care providers to screen patients for hepatitis B prior to initiating treatment and to discontinue the drug in patients who develop the condition.

The FDA did not mention that the boxed warning in the new Arzerra label also includes a warning that the drug can cause progressive multifocal leukoencephalopahy (PML). PML is a rare disease caused by the John Cunningham virus, which is common and almost always harmless in humans, but it can attack those with compromised immune systems, such as those of people on immunosuppressants like Arzerra. PML destroys the fatty covering of the brain called myelin, thereby impairing transmission of electrical signals in the brain. Symptoms of this disease include:

  • Weakness
  • Impaired speech
  • Vision loss
  • Paralysis
  • Cognitive deterioration

An MRI can detect PML, but other than blood plasma transfusions to cycle the drug out of the body no effective treatment exists. Patients usually die within four months of being diagnosed.

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Arzerra lawsuit on your behalf if necessary.

If you or a loved one has taken Arzerra, and you believe it caused an injury, contact RLG today.

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