The U.S. Food and Drug Administration (FDA) has put forth an urgent safety alert, in regards to some rare but very life-threatening risks including stroke and artery rupture. The patients at risk are those who have relapsing forms of multiple sclerosis (MS) and are currently being treated with Lemtrada (alemtuzumab).
Since Lemtrada’s approval in 2014 to treat relapsing MS, 13 cases worldwide have been reported to the FDA of ischemic stroke (caused by clots) and hemorrhagic stroke (caused by bleeds) or of tears in head and neck arteries. All these cases are associated with the medicine’s use. The FDA announced it has added a new warning about these serious risks — which could lead to permanent disability or death — to the prescribing information on the drug label and the patient Medication Guide. This information comes highlighted in a “boxed warning,” or FDA’s highest warning level.
Fast Facts About Lemtrada
- Lemtrada helps reduce the frequency and severity of “attacks” or “relapses,” of MS
- Lemtrada is administered by intravenous infusion and is given as a last treatment option
- Because of its safety profile it is use only after other treatments have failed
- Common side effects of Lemtrada include infusion-related reactions and infections
- Lemtrada can also cause a number of other serious adverse reactions
- Alemtuzumab is also known as Campath used for B-cell chronic lymphocytic leukemia
FDA Warning for lemtrada Patients and Caregivers
According to official FDA statements about the risks of Alemtuzumab: Patients or their caregivers should seek emergency treatment immediately if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries. The most commonly seen symptoms can include:
- Sudden numbness or weakness in the face, arms, or legs, on only one side of the body
- Sudden confusion, difficulty speaking, slurred speech, or trouble processing speech
- Sudden vision trouble in either one eye or both eyes at the same time
- Sudden difficulty with walking, dizziness, poor balance, or loss of coordination
- Sudden severe headache, pain behind the eyes, neck pain, or trouble moving neck/head
- Most symptoms developed within 1-2 days of receiving the first treatment of Lemtrada
In November 2018, the FDA warned that Lemtrada (alemtuzumab) is linked to multiple reports of strokes and arterial dissection, a severe side effect in which blood vessels tear in the head or neck.
“In the nearly five years since FDA approved Lemtrada in 2014 to treat relapsing forms of MS, we identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada. This number includes only reports submitted to FDA, so additional cases we are unaware of may have occurred. Twelve of these cases reported symptoms within 1 day of receiving Lemtrada” (FDA).
If you or a loved one has suffered an ischemic or hemorrhagic stroke or been diagnosed with a form of arterial dissection, you may be entitled to compensation by filing a lawsuit. A lawsuit of this nature could fall under one of several types of personal injury cases depending on the details of the individual case, extent of the injuries, and how the medication was prescribed.
Medical malpractice is the legal term used for personal injury cases that revolve around an act of negligence by a medical practitioner that results in serious injury or the death of a patient under their care or supervision. Under personal injury law, the injured party can sue the medical team or doctors for damages to compensate for their medical care, the cost of further care stemming from their injuries and for loss of quality of life. In the event of death due to the actions or inactions of a medical professional, surviving family members may be able to sue for compensation as well in their personal injury cases.
Defective medicines refer to the area of personal injury cases where a plaintiff can collect damages if they took any medication that caused injury beyond what was disclosed to them as possible side effects of the medication. Injuries resulting from a defective medicine usually target the manufacturer of the medicine though others may also be involved as secondary or co-defendants in some cases. These lawsuits are often class action suits because multiple individuals are affected and are ringing a strong case against the defendant all at once. After taking a defective drug that caused undisclosed side effects, a plaintiff can sue in order to collect for medical expenses, lost wages, pain and suffering, and decreased quality of life among others.
Contact a lawyer Today
If you have suffered injury or a loved one had died because of the side effects of Lemtrada, contact a lawyer today. Our team of legal experts can help you find the right legal course of action for you and we will work with you very step of the way. You deserve to get compensation for the pain and suffering you and your family have been through and to get compensation for the injuries and medical care that has been incurred now. We can help you fight Big Pharma, the medical industry, and the drug manufacturers so you can get back at least part of your life. Call now and schedule a consultation appointment with our legal team. We are here for you today, so call us now and fight back for what you deserve.