Lupus is an autoimmune disease that still has many years ahead of it before it is properly understood. In the meantime, many doctors prescribe a variety of medications to help reduce and manage the symptoms of this chronic disease. Many medications are carefully tested and scrutinized before going on the market but despite this, some medications ship with serious risks. One such medication was reported in early April. The medication Benlysta’s mental health risks were first reported on by Health Canada, but their potential harms are too severe to overlook in the U.S.
What Are Benlysta’s Mental Health Risks?
Belimumab, better known by its brand name Benlysta, is a human IgG1 monoclonal antibody that affects the soluble human B Lymphocyte Stimulator, which is an area usually affected by autoantibody-positive, systemic lupus erythematosus (SLE). Belimumab is cleared for use in tandem with standard procedures for treating SLE activity in adults.
In a recent study, lasting one year with over 4,000 subjects with SLE, trends began to emerge between Benlysta and serious mental health complications. Benlysta’s mental health risks were found in many patients and commonly manifested in the following ways:
- Severe depression
- Suicidal thoughts and actions
- Self-harm
- Suicide
When compared with the control, patients with SLE who were taking Benlysta were reported to have a far higher incidence rate and this was the basis for Health Canada’s warning about Benlysta’s mental health risks.
Though Benlysta’s mental health risks had been documented previously on Canada’s black box label, that did not stop at least two unfortunate victims from claiming their own lives. Benlysta may be legal for the time being, but its mental health risks have clearly not been taken seriously enough.
How Are Benlysta’s Mental Health Risks Being Managed?
In response to the results produced about Benlysta’s mental health risks, Health Canada has released the following guidelines for consumers and doctors in order to prevent additional adverse mental health complications in users:
- Physicians must evaluate the risk of a patient developing depression, suicidal thoughts or actions, or patterns of self-injury, before adding Benlysta to a treatment regimen.
- While taking Benlysta, patients should be regularly checked or screened for any signs of depression or concerning activity.
- If a patient’s depression worsens, or the patient becomes depressed, a healthcare professional should be brought in to assist in the mental health care of the patient.
In addition to releasing these guidelines, Health Canada is maintaining a communication line to healthcare professionals and the public via the Recalls and Safety Alerts Database. This line of communication will allow Health Canada to publish alerts and safety information to the public as soon as it is verified as factual. Additionally, Health Canada has also entered into discussions with the GSK group about updating the Benlysta product description.
Recovering From Exposure To Benlysta’s Mental Health Risks
The efforts of Health Canada in curbing Benlysta’s mental health risks is emblematic of a government taking action to protect its citizens. In America, however, the U.S. Food and Drug Administration (FDA) is not currently acting on this information.
At the time of this publication, the FDA only cites depression on their official report about Benlysta’s mental health risks and side effects. While Americans wait for the FDA to catch up with the rest of the world, American lives may be in danger.
Depression and self-harm are often hard to notice without specifically screening for it, and mental health can be difficult to monitor at a glance. However, this is not an excuse to negligently allow a product to continue without an update to its black box label to ensure it is screened properly by medical professionals. If you or a loved one have experienced suicidal thoughts or actions, self-harm, or other depression-related conditions while taking Benlysta, don’t wait, let Parker Waichman fight for you. At Parker Waichman LLP teams of experienced trial lawyers can help you and your family recover the compensation necessary to get help and move on with your lives. Don’t wait. Contact Parker Waichman today for a free consultation.
For more coverage of Parker Waichman’s experiences with faulty product visit the link here.
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