The U.S. Food & Drug Administration (FDA) has issued a press release warning the public that a potentially-deadly brain infection known as progressive multifocal leukoencephalopathy (PML) has been linked to the lymphoma drug Adcetris (brentuximab vedotin). Signs and symptoms of Adcetris-induced PML include changes in mood or usual behavior, confusion, thinking problems, decreased strength, and weakness on one side of the body. Due to the severity of PML, a new Boxed Warning highlighting this risk has been added to Adcetris labels.
Free Adcetris Progressive Multifocal Leukoencephalopathy (PML) Lawsuit Evaluation: If you or a loved one has been diagnosed with PML after being treated with Adcetris, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Adcetris and we can help.
What’s the problem?
To date, there have been at least three cases of progressive multifocal leukoencephalopathy in Adcetris users reported to the FDA. At the time of Adcetris’ approval in August 2011, a single case of PML was cited in the Warnings and Precautions section of the drug’s label.
Adcetris is a CD30-directed antibody-drug conjugate (ADC) indicated for the treatment of Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL). These diseases are cancers of the lymphatic system. Adcetris contains an antibody that directs the drug to a target on lymphoma cells known as CD30.
Adcetris is intended to be used in patients whose condition has advanced after stem cell transplant, or after two prior chemotherapy treatments for those who cannot receive a transplant. The drug may also be used to treat individuals with ALCL whose condition has advanced after one chemotherapy treatment.
Progressive Multifocal Leukoencephalopathy
PML is a rare but extremely serious disorder that damages the myelin that covers and protects nerves in the white matter of the brain. The disease typically occurs in individuals undergoing chronic corticosteroid or immunosuppressive therapy for organ transplant, or in patients with Hodgkin’s disease or lymphoma. People with autoimmune conditions such as multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosis are at an increased risk for PML as well.
Progressive Multifocal Leukoencephalopathy is most common among patients with HIV and AIDS. Research suggests that prior to effective antiretroviral therapy (ART), approximately five percent of patients infected with HIV eventually develop PML. However, modern techniques involving ART are able to effectively restore immune system function, allowing as many as half of all HIV-PML patients to survive, although they may sometimes have an inflammatory reaction in the regions of the brain affected by PML.
Signs and symptoms of Adcetris-induced PML are diverse, since they are related to the location and amount of damage in the brain, and may evolve and manifest themselves differently over time. The most prominent symptoms include:
- loss of coordination, clumsiness
- loss of language ability (aphasia)
- memory loss
- vision problems
- weakness of the legs and arms that gets worse
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Treatment & Prognosis (Outlook)
The best treatment currently available for PML is reversal of the immune-deficient state, since there are no effective medications that are able to block virus infection without toxicity. Reversal may be accomplished through plasma exchange to accelerate the removal of the therapeutic agents that put patients at risk for PML. In the case of HIV-associated PML, immediately beginning anti-retroviral therapy will benefit most patients.
PML typically has a mortality rate between 30-50% in the few months following the initial diagnosis, but the long-term outlook largely depends on the severity of the underlying disease and treatment received. Those who manage to survive PML are usually left with severe lifelong neurological disabilities.
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Do You Have an Adcetris Progressive Multifocal Leukoencephalopathy (PML) Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Adcetris lawsuits. We are handling individual litigation nationwide and currently accepting new Adcetris Progressive Multifocal Leukoencephalopathy (PML) cases in all 50 states.
Free Adcetris Progressive Multifocal Leukoencephalopathy (PML) Lawsuit Evaluation: If you or a loved one has been diagnosed with PML after being treated with Adcetris, you should contact our law firm immediately. You may be entitled to compensation by filing an Adcetris PML suit and we can help.