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According to the U.S. Food and 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 relapsing remitting multiple sclerosis. These complications most often occur shortly after receiving Lemtrada treatment —usually within one day—and they can lead to permanent disability or even death.
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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 drug and device manufacturers and our lawyers can help.

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What’s the Problem With the Multiple Sclerosis Drug Lemtrada?

On Nov. 28, 2018, the FDA issued a warning which stated that alemtuzumab, an MS drug found in the brand names Lemtrada and Campath, had been linked to “serious cases of stroke or arterial dissection,” which could lead to “permanent disability and even death.”

“FDA is warning that rare but serious cases of ischemic stroke and tears in the lining of arteries in the head and neck have occurred in patients with medical conditions including relapsing 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 in clinical trials, FDA has required a boxed warning about these risk factors in the prescribing information, as well as in the Patient Medication Guide.

“MS Patients or their caregivers should seek emergency Lemtrada treatment as soon as possible if the patient experiences signs or symptoms of a ischemic stroke or tears in the lining of the head and neck arteries,” FDA said.

Related Article: MS Treatment Drug Zinbryta Lawsuit

Lemtrada Side Effects

Rare but serious risks of Lemtrada include:

  • Stroke
  • Hemorrhagic stroke
  • Neck arterial dissections
  • Artery tears
  • Blood vessel tears
  • Tears in the lining of arteries in the head and neck
  • Immune system attacks
  • Central nervous system problems
  • Autoimmune disease
  • Fatal bilateral intracerebral hemorrhage

Common side effects include:

  • Rash
  • Headache
  • Fever
  • Nasal congestion
  • Swelling of the blood vessels
  • Nausea
  • Urinary tract infection
  • Fatigue
  • Insomnia
  • Upper respiratory tract infection
  • Herpes viral infection
  • Fungal infection
  • Hives or itching
  • Thyroid gland disorders
  • Pain in the joints, extremities, or back
  • Diarrhea
  • Sinusitis
  • Sore mouth or throat
  • Tingling feeling
  • Dizziness
  • Abdominal pain
  • Vomiting
  • Flushing of the face, neck, or chest
  • Other risk factors

Arterial Dissection Symptoms

  • Sudden numbness or weakness in the face, arms, legs, head or neck 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

Stroke Symptoms

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, leg, head or neck
  • 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
  • Headache
  • Trouble with walking
  • Sudden dizziness, loss of balance or loss of coordination

What is Lemtrada?

The FDA approved Lemtrada in 2014. The drug 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.

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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:

“Healthcare professionals should advise patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms of ischemic and 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.”

 

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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 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.

Neck Arterial Dissection

 

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.

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