Lemtrada is an FDA-approved disease-modifying treatment designed to slow down the progression of relapsing-remitting multiple sclerosis (MS). Because of its safety profile, Lemtrada is only available in the United States through a restricted distribution program and its use is generally reserved for patients who have had an inadequate response to two or more MS drugs. In addition to other possible Lemtrada side effects, the FDA has issued a warning about the risk of rare but serious strokes and head or neck arterial dissections possibly leading to permanent disability or death in MS patients who received Lemtrada. If you or someone you loved has suffered a stroke or arterial dissection and you believe the MS treatment Lemtrada to be the cause, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by dangerous and defective medications and we can help put you in touch with an experienced Lemtrada injury lawyer today.
If you have been diagnosed with a relapsing form of MS and you are considering Lemtrada treatment, it is important to understand the potential risks associated with the intravenous infusion. Lemtrada was approved by the FDA based on the results of clinical trials that showed its potential to reduce relapse rates in patients with relapsing forms of MS, but the drug has since been linked to serious and potentially deadly side effects in MS patients. MS is a condition that affects more than two million people worldwide and treatment generally targets the symptoms of the disease, as the cause of MS is unknown. There is no cure for MS, but there are natural alternatives to Lemtrada that may help reduce symptoms or slow the progression of the disease, including the following herbs and supplements:
Lemtrada (alemtuzumab) is a disease modifying drug (DMD) indicated for the treatment of relapsing-remitting multiple sclerosis, a chronic autoimmune disease affecting the central nervous system. In patients with MS, the immune system attacks the fatty substance responsible for protecting and insulating nerve fibers in the spinal cord and brain, known as myelin. This causes a disruption in the communication between nerves, resulting in a number of debilitating neurological symptoms.
The FDA approved Lemtrada in 2014 as an infusion therapy for MS and the drug is administered intravenously in two treatment courses. The first course of Lemtrada treatment is administered at a dose of 12mg per day over five consecutive days, followed by a second course, 12 months later, at a dose of 12mg per day for three consecutive days. According to the FDA, alemtuzumab is also sold under the brand name Campath, which was approved in 2001 for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
Despite its efficacy in reducing the number of relapses in patients with MS, the use of Lemtrada has been restricted by serious and potentially fatal side effects. In fact, Lemtrada is only available in the United States through a restricted distribution program known as Lemtrada REMS (Risk Evaluation and Mitigation Strategy). Due to the potential side effects associated with Lemtrada treatment, the drug is typically only prescribed to relapsing MS patients who have already been treated with two or more other medications with an inadequate response.
Lemtrada treatment has been linked to a possible increased risk of the following side effects in users:
Strokes and arterial dissections can result in serious and potentially life-threatening complications and disabilities, including:
In November 2018, the FDA issued a drug safety communication warning that “rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab).” The agency also warned in the same safety communication that “These problems can lead to permanent disability and even death.” At that time, the FDA encouraged MS patients or their caregivers to watch out for symptoms of a stroke or arterial dissections, which may include:
Since the FDA approved Lemtrada in 2014, the agency has identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection occurring in patients treated with the drug. And of those 13 cases, 12 developed symptoms within just one day of receiving Lemtrada treatment. Following the 2018 FDA warning, a neurologist identified five additional cases of intracerebral hemorrhage (ICH) in MS patients treated with Lemtrada. According to the report, in all five cases, the ICH occurred during the initial five-day infusion period and none of the patients had any prior history of stroke, bleeding disorders, aneurysm or other risk factors for ICH.
In 2013, Sanofi was hit with a class action lawsuit over claims that the drug maker made misleading statements about the safety and efficacy of Lemtrada. The complaint came on the heels of the FDA’s refusal to approve Lemtrada as a treatment for MS. The more recent controversy surrounding Lemtrada and the potential for the drug to cause serious and unexpected side effects in users, including stroke and arterial dissection occurring in the head or neck, has led attorneys nationwide to explore cases against Sanofi Genzyme for injuries allegedly caused by the infusion therapy.
September 2013 – Lemtrada is approved by European regulators.
December 2013 – The FDA refuses to approve Lemtrada, citing the need for additional trials to evaluate the drug’s safety and effectiveness.
November 2014 – Lemtrada is approved by the FDA.
November 2018 – The FDA issues a drug safety communication warning that serious and potentially life-threatening cases of stroke and head or neck arterial dissection have occurred in MS patients treated with Lemtrada. The agency updates Lemtrada’s Boxed Warning to include information about these risks.
April 2019 – The European Medicines Agency restricts the use of Lemtrada while it conducts a safety review of the MS drug.
October 2015 – A case study highlights an ischemic stroke with spontaneous multiple cervical artery dissections occurring in a 40-year-old woman with relapsing MS during a first course of Lemtrada treatment.
February 2019 – A case study highlights a fatal bilateral intracerebral hemorrhage following treatment with Lemtrada for MS. According to the study conclusion, “Under consideration of the clinical cause and the neuropathological findings, it is suggested that a causal connection exists between the alemtuzumab treatment and the ICH, which was possibly mediated by vascular damage.”
April 2019 – A case study published by The Lancet highlights the risk of intracerebral hemorrhage occurring during Lemtrada treatment, identifying five additional cases of intracerebral hemorrhage in MS patients treated with Lemtrada.
Patients suffering from serious medical conditions like multiple sclerosis deserve to be informed of the risks of the treatments they undergo and drug companies like Sanofi that fail to adequately warn patients and healthcare providers about the potential side effects associated with their medications must be held accountable. When used to treat relapsing MS, Lemtrada has been known to pose certain risks to users, but these risks were not identified when many MS patients began using Lemtrada. As more information comes to light about the potential for Lemtrada to cause stroke and head or neck arterial dissection in MS patients, lawsuits are expected to be filed by former Lemtrada users, accusing Sanofi of:
Although Lemtrada therapy has been shown to reduce the number of MS relapses in patients by about two-thirds, compared to taking a placebo, the potential risk of stroke and head or neck arterial dissection has raised serious concerns about the safety of Lemtrada. Product liability lawyers across the country are currently investigating claims by MS patients who suffered strokes, head or neck arterial dissections and other side effects allegedly caused by Lemtrada treatment. If you or a loved one received Lemtrada for multiple sclerosis and experienced a stroke or arterial dissection within a few days of the treatment, you may be entitled to financial compensation for your medical expenses, lost wages, pain and suffering, and other damages. Contact an experienced Lemtrada injury attorney as soon as you can to discuss the possibility of filing a Lemtrada lawsuit against Sanofi.