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Complications, Recalls & Legal Help
Benlysta (Belimumab) is a prescription medication used alongside standard therapies to treat adults with systemic lupus erythematosus (SLE). While it was marketed as an important advancement for lupus patients, the drug has been linked to severe, and sometimes fatal, adverse reactions. These risks include dangerous infections, progressive multifocal leukoencephalopathy (PML), cardiac complications, significant psychiatric side effects, and increased mortality rates during clinical trials.
Carabin Law is actively reviewing claims from individuals who experienced serious harm after taking Benlysta.
How Benlysta Works
Benlysta targets and suppresses specific B-cells that fuel the overactive immune response seen in lupus. Approved by the FDA in 2011 and produced by GlaxoSmithKline, it is typically administered through intravenous infusion. Because the drug alters the immune system, it can leave patients highly vulnerable to infection and other system-wide complications.
Common Side Effects Reported by Patients
While many patients experience only mild reactions, such as:
Nausea or diarrhea
Fever
Runny nose or sore throat
Bronchitis
Sleep problems
Depression
Headaches
others suffer far more dangerous outcomes that require immediate medical care.
Serious and Potentially Life-Threatening Reactions
Because Benlysta suppresses immune function, patients may face increased risk of infections that quickly become dangerous, including:
These infections may require hospitalization and can lead to long-term complications.
Benlysta users have reported serious heart-related reactions such as:
Chest pain or discomfort
Shortness of breath
Nausea or cold sweats
Dizziness
In vulnerable patients, these symptoms can escalate into cardiac emergencies.
One of the most concerning findings is the increased rate of psychiatric side effects, including:
Suicidal thoughts
Suicide attempts
Anxiety or worsening depression
Insomnia
Sudden or extreme mood changes
These reactions were observed at higher rates in Benlysta clinical trials than in placebo groups.
Because the drug alters immune activity, some evidence suggests a possible increased risk of developing certain cancers, another factor patients may not have been adequately warned about.
One of the most severe risks linked to Benlysta is PML, a rare but often fatal brain infection. PML is more likely to occur in individuals taking medications that weaken the immune system.
Symptoms of PML may include:
Memory loss or confusion
Balance problems
Vision changes
Difficulty walking or speaking
PML causes permanent neurological damage and can lead to rapid decline or death.
Clinical Trials Show a Higher Rate of Psychiatric Events and Death
During controlled clinical trials, patients receiving Benlysta reported psychiatric side effects more frequently than those given a placebo. Additionally, the mortality rate was higher among Benlysta recipients, 14 deaths were documented across pivotal trials.
These findings raise significant concerns about the drug’s safety profile and the adequacy of warnings provided to patients and healthcare providers.
Injured? Contact Carabin Law
If you or a loved one experienced severe side effects after using Benlysta, Carabin Law can review your case at no cost.
Free and confidential consultation
No fees unless compensation is recovered
Serving clients across Texas
Contact Carabin Law today to learn more about your rights.