According to the U.S. Food & Drug Administration (FDA), Lemtrada may increase the risk of arterial dissection, which can lead to strokes and arterial tearing in the head and neck areas of patients with multiple sclerosis. These complications most often occur shortly after receiving the drug—usually within one day—and they can lead to permanent disability or even death.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by the side effects of Lemtrada (alemtuzumab), you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
On Nov. 28, 2018, the FDA issued a warning on Lemtrada stating that alemtuzumab, a multiple sclerosis drug found in the brand names Lemtrada and Campath, had been linked to “serious cases of stroke and tears in the lining of arteries in the head and neck,” which could lead to “permanent disability and even death.”
“FDA is 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 said. “These problems can lead to permanent disability and even death.”
As a result of the problems with alemtuzumab, FDA has required a boxed warning about these risks in the prescribing information, as well as in the Patient Medication Guide.
“Patients or their caregivers should seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection,” FDA said.
Lemtrada Side Effects
Serious side effects of Lemtrada include:
- Arterial dissection
- Tears in the lining of arteries in the head and neck
Common side effects include:
- Nasal congestion
- Swelling of the nose or throat
- Urinary tract infection
- Upper respiratory tract infection
- Herpes viral infection
- Fungal infection
- Hives or itching
- Thyroid gland disorders
- Pain in the joints, extremities, or back
- Sore mouth or throat
- Tingling feeling
- Abdominal pain
- Flushing of the face, neck, or chest
Arterial Dissection Symptoms
- Sudden numbness or weakness in the face, arms, or legs, especially if it occurs on only one side of the body
- Sudden confusion, trouble speaking, or difficulty understanding speech
- Sudden trouble seeing in one or both eyes
- Sudden trouble with walking, dizziness, or loss of balance or coordination
- Sudden severe headache or neck pain
According to the Mayo Clinic, signs and symptoms of a stroke may include:
- Trouble with speaking and understanding
- Paralysis or numbness of the face, arm or leg
- Sudden numbness, weakness or paralysis in your face, arm or leg
- One side of your mouth may droop when you try to smile
- Trouble with seeing in one or both eyes
- Trouble with walking
- Sudden dizziness, loss of balance or loss of coordination
What is Lemtrada?
Approved by the FDA in 2014, Lemtrada is used to treat relapsing forms of multiple sclerosis. The drug works by binding to and killing immune cells that attack myelin; it is believed that the immune cells which grow back after treatment do not cause nerve damage. Lemtrada is manufactured and marketed by Sanofi-SA.
Lemtrada is a disease-modifying therapy for people with relapsing forms of multiple sclerosis. The drug is initially administered intravenously (IV) for 5 consecutive days, and for 3 consecutive days one year later. Due to its risky safety profile, the Prescribing Information (PDF) states that Lemtrada should generally only be used on patients who have had poor responses to 2 or more other multiple sclerosis therapies.
MS Drugs Must Carry Stroke Warning: FDA Health Alert
FDA is henceforth requiring all alemtuzumab-containing medications to carry its most severe “Black-Box Warning”, as well as a warning in the drugs’ Medication Guide, describing the risk of stroke and blood vessel wall tears.
FDA Recommendation to Healthcare Professionals
FDA is advising anyone taking Lemtrada to call a doctor right away if they experience any of the above symptoms of stroke or arterial dissection:
“Healthcare professionals should advise patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection,” the agency said. “The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific. Promptly evaluate patients who complain of symptoms consistent with these conditions.”
Can I File a Lemtrada Lawsuit?
Only a qualified lawyer can determine whether you are eligible to file a lawsuit against Sanofi, the maker of Lemtrada, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm for a free case review.
Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of Lemtrada, our lawyers suspect that patients may be able to take legal action in light of claims that Sanofi failed to adequately warn doctors and patients about the risk of stroke and arterial dissection.
Has there been a class action filed on Lemtrada? No class action has been filed for Lemtrada stroke or arterial dissection lawsuits.
How Can Filing a Complaint Help Me?
By filing a lawsuit against the makers of Lemtrada, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your injury, as well as for damages for pain and suffering. Additionally, filing a Lemtrada lawsuit can help hold the drug’s manufacturer accountable for releasing an allegedly defective drug into the marketplace, and to discourage other pharmaceutical companies from engaging in similar conduct.
Do I Have a Lemtrada Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Lemtrada lawsuits. We are handling individual litigation nationwide and currently accepting Lemtrada side effect cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one has been injured by the side effects of Lemtrada (alemtuzumab), you should contact our law firm immediately by using the form below or dialing (866) 588-0600. You may be entitled to compensation by filing a Lemtrada lawsuit and we can help.