The U.S. Food and Drug Administration (FDA) has required a boxed warning about the side effects of Campath. Specifically, the FDA has warned that Campath patients have an increased risk of arterial problems, which can lead to strokes and arterial tearing in patients with multiple sclerosis.
“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 arteries, called arterial dissection,” the agency said.
Free Case Evaluation: If you or a loved one has been injured by the side effects of Campath (alemtuzumab), you should contact our law firm immediately for a free case evaluation. 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 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 [1] about these risks in the prescribing information, as well as in the Patient Medication Guide.
What is Campath?
Campath is a recombinant monoclonal antibody used as a treatment for chronic lymphocytic leukemia (CLL), a form of cancer. The drug works by attaching itself to an antigen in the body’s immune system called CD52, which destroys these targeted cells in the blood and bone marrow. Click on this link to view the Campath Package Insert [2].
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Campath Side Effects
Serious side effects of Campath include:
- Stroke
- Arterial dissection
- Tears in the lining of arteries in the head and neck
Arterial Dissection Symptoms
- Sudden numbness or weakness in the face or arms, especially if it occurs on only one side of the body
- Leg sudden numbness
- Walking sudden dizziness
- 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
- Trouble with speaking and understanding
- Paralysis or numbness of the face, arm or leg
- Sudden confusion
- One side of your mouth may droop when you try to smile
- Trouble with seeing in one or both eyes
- Headache
- Trouble with walking
- Loss of balance or loss of coordination
MS Drugs Must Carry Black Box 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 [3], describing the risk of stroke and blood vessel wall tears.
FDA Recommendation to Healthcare Professionals
FDA is advising anyone taking Campath 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 Campath 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.”
Has there been a class action filed on Campath? No class action has been filed for Campath stroke or arterial dissection lawsuits.
Get a Free Campath Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Campath lawsuits. We are handling individual litigation nationwide and currently accepting Campath side effect cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one has been injured by the side effects of Campath (alemtuzumab), you should contact our law firm immediately for a free case review by using the form below or dialing (866) 588-0600. You may be entitled to compensation by filing a Campath lawsuit against other pharmaceutical companies and we can help.
