The U.S. Food and Drug Administration (FDA) believes that the anti-lymphoma drug brentuximab vedotin—sold under the brand name Adcetris—might cause Progressive Multifocal Leukoencephalopathy, pulmonary toxicity, and other side effects, resulting in symptoms such as impaired speech, vision loss, and paralysis.
What Is Adcetris? When Is It Prescribed?
Adcetris is the brand name for the drug brentuximab vedotin. Made and sold by an American pharmaceutical company, Seattle Genetics, Inc., this prescription medication is used to treat two conditions: Hodgkin’s lymphoma and anaplastic large cell lymphoma. The FDA approved Adcetris in August 2011 as an intravenous infusion. As of January 2012, 2,000 people had received Adcetris lymphoma treatment.
Adcetris is an “antibody-drug conjugate,” which means it consists of a drug with an antibody attached to it. The antibody binds the drug to cancer cells and then the drug attacks them. This process allows targeted cancer therapy with fewer side effects than other methods. Adcetris might cause dangerous side effects that could affect the lungs and brain.
Adcetris Might Cause Life-Threatening Side Effects
The FDA believes Adcetris might cause the following side effects:
- Progressive Multifocal Leukoencephalopathy
- pulmonary toxicity
- other side effects
Progressive Multifocal Leukoencephalopathy
Progressive Multifocal Leukoencephalopathy is a potentially fatal brain disease characterized by inflammation of the brain’s white matter at multiple locations. The disease, caused by the JC virus, destroys a large number of its victims’ brain cells, which impairs transmission of electrical signals in the brain. Symptoms of this terrifying disease include:
- impaired speech
- vision loss
- cognitive deterioration
A Magnetic Resonance Imaging (MRI) scan can detect PML, but no known treatment exists. Patients usually die within four months of being diagnosed.
On January 12, 2012, the FDA issued an Adcetris Progressive Multifocal Leukoencephalopathy warning in a drug safety communication. The FDA received information about two additional Adcetris patients developing PML, raising the total number of cases to three. Two of the individuals were men aged 48 and 50 years old, and the third was a 38-year-old woman. The 48-year-old man died from the disease. As a result the FDA announced that the Adcetris drug label now contains a black box warning, the FDA’s most serious kind, because the drug’s interaction with the immune system might inhibit its ability to fight the JC virus, allowing it to cause PML.
In the same drug safety communication, the FDA noted that when combined with bleomycin, Adcetris might cause pulmonary toxicity. Symptoms of pulmonary toxicity include:
- lung inflammation
- lung fibrosis
The Adcetris drug label now includes a contraindication for using it with bleomycin.
Other Adcetris Side Effects
The “Warnings and Precautions” section of Adcetris’s drug label also includes entries for the following conditions:
- peripheral neuropathy – pain or tingling sensations
- infusion reactions
- neutropenia – deficiency in neutrophils, a type of white blood cell
- tumor lysis syndrome – metabolic complications caused by the byproducts of dying cancer cells
- Stevens-Johnson Syndrome – a potentially fatal skin condition in which the layers of the skin separate
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. We will file an Adcetris lawsuit on your behalf if necessary.
If you have taken Adcetris and believe it harmed you, contact RLG today.