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Lemtrada

Lemtrada, a drug indicated for certain types of multiple sclerosis, is linked to serious and potentially fatal risks of stroke and head and neck arterial dissection.

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Did you experience complications after taking Lemtrada?

What Is Lemtrada?

Lemtrada (alemtuzumab) is a drug indicated for certain types of multiple sclerosis (MS), a disease of the central nervous system. It is approved for use in patients who have relapsing forms of MS. Lemtrada is administered by intravenous (directly into a vein) infusion in two treatment cycles occurring 12 months apart. 1

Alemtuzumab was originally approved in 2001 as the biologic Campath, indicated for B-cell chronic lymphocytic leukemia. 2 It was approved for MS under the name “Lemtrada” in 2014. 3

Serious Side Effects

Lemtrada is linked to potentially fatal adverse reactions including:

  • Ischemic stroke. 4
  • Hemorrhagic stroke. 5 6
  • Head or neck (cervicocephalic) arterial dissection (blood vessel tears). 7 8

Strokes and blood vessel tears can be deadly. They can also result in serious complications and life-long disability such as:

  • Muscle weakness and numbness.
  • Language disorder (aphasia) or speech loss.
  • Motor disorder (apraxia) and inability to carry out everyday tasks.
  • Vision loss.
  • Memory and attention problems.
  • Depression.
  • Death. 9 10 11 12 13

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued warnings about Lemtrada’s risks. The FDA mandated the addition of its most serious warning, a boxed warning, regarding the risk of stroke, and another warning in the label regarding cervicocephalic arterial dissection. 14 15 The EMA began a safety review and restricted Lemtrada’s use to patients with “highly active” MS “despite treatment with at least two disease-modifying therapies…or where other disease-modifying therapies cannot be used.” 16

When Side Effects Can Occur?

The FDA announced it found in its review of adverse event reports that strokes and tears in the lining of arteries in the head or neck appear to typically occur within three days of administration of Lemtrada. In their safety announcement, the FDA notes that, “Most patients taking Lemtrada who developed stroke or tears in the artery linings, developed symptoms within 1 day of receiving Lemtrada.” 17

In one of the earliest reports of ischemic stroke and arterial dissection, published in 2015, a 40-year-old woman experienced a stroke three days after completing a five-day course of infusions. 18

Often the reaction is more sudden. A paper presenting five reports of MS patients who received Lemtrada and then had an intracranial hemorrhage (ICH) notes they all experienced the ICH within “several hours after leaving the infusion centre.” 19

Signs and Symptoms of Stroke and Arterial Dissection

Symptoms of stroke and head and neck arterial dissection may include sudden onset of:

  • Numbness or weakness, especially of the face or an arm or leg.
  • Confusion, including inability to understand speech.
  • Poor vision.
  • Slurred speech or trouble speaking.
  • Headache or neck pain.
  • Balance issues, or trouble walking. 20

What To Do If You’re Experiencing Symptoms

Seek immediate medical attention if you experience any of the symptoms of stroke or arterial dissection. Speedy treatment can mean the difference between recovery, and lasting disability or even death. 21

If you or a loved one experienced a stroke or arterial dissection after receiving Lemtrada for the treatment of MS, you may be entitled to compensation for medical expenses, pain and suffering, and lost wages, among other claims.

Patients who experienced these issues after receiving Lemtrada are reaching out to attorneys. Lawsuits are currently being filed on behalf of these patients who suffered these dangerous side effects without ever having been warned of the risks.

  1. Prescribing Information. (2019, January). LEMTRADA® (alemtuzumab) injection, for intravenous use. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf
  2. U.S. Food & Drug Administration. (2018, November 29). FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-serious-risks-stroke-and-blood-vessel-wall-tears-multiple-sclerosis-drug
  3. Ibid.
  4. Durand-Dubief, F., et al. (2015). Ischemic stroke with spontaneous multiple cervical artery dissections in a 40-y old woman during a first course of alemtuzumab: cause or coincidence? Multiple Sclerosis Journal. Retrieved from https://onlinelibrary.ectrims-congress.eu/ectrims/2015/31st/115247/francoise.durand-dubief.ischemic.stroke.with.spontaneous.multiple.cervical.html?f=m1
  5. Sinicina, I., et al. (2019, February 4). Fatal bilateral intracerebral hemorrhage following treatment with alemtuzumab for multiple sclerosis. Rechtsmedizin Case Reports. Retrieved from https://link.springer.com/article/10.1007/s00194-019-0299-1
  6. Durand-Dubief, F., et al. (2015). Ischemic stroke with spontaneous multiple cervical artery dissections in a 40-y old woman during a first course of alemtuzumab: cause or coincidence? Multiple Sclerosis Journal. Retrieved from https://onlinelibrary.ectrims-congress.eu/ectrims/2015/31st/115247/francoise.durand-dubief.ischemic.stroke.with.spontaneous.multiple.cervical.html?f=m1
  7. Azevedo, C. J., et al. (2019, April). Intracerebral haemorrhage during alemtuzumab administration. The Lancet Neurology. Retrieved from https://www.thelancet.com/action/showPdf?pii=S1474-4422%2819%2930076-6
  8. U.S. Food & Drug Administration. (2018, November 29). FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-serious-risks-stroke-and-blood-vessel-wall-tears-multiple-sclerosis-drug
  9. Langhorne, P., et al. (2000, June). Stroke. Medical Complications After Stroke. A Multicenter Study. Retrieved from https://www.ahajournals.org/doi/full/10.1161/01.STR.31.6.1223
  10. American Heart Association. (2015). Let’s Talk About. Complications After Stroke. Retrieved from https://www.strokeassociation.org/-/media/stroke-files/stroke-resource-center/recovery/patient-focused/spost_complicationsafterstk_2015.pdf
  11. National Institutes of Health. (2014, September). Post-Stroke Rehabilitation. Retrieved from https://www.stroke.nih.gov/materials/rehabilitation.htm
  12. McKevitt, C., et al. (2011, May 1). Self-Reported Long-Term Needs After Stroke. Stroke. Retrieved from https://www.ahajournals.org/doi/10.1161/STROKEAHA.110.598839
  13. Roberts, S. E., et al. (2015, June 29). Mortality following Stroke, the Weekend Effect and Related Factors: Record Linkage Study. PloS one. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4487251/
  14. Prescribing Information. (2019, January). LEMTRADA® (alemtuzumab) injection, for intravenous use. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103948s5163s5164slbl.pdf
  15. U.S. Food & Drug Administration. (2018, November 29). FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-serious-risks-stroke-and-blood-vessel-wall-tears-multiple-sclerosis-drug
  16. Brennan, Z. (2019, April 12). EMA Begins Safety Review of MS Drug Lemtrada. Regulatory Focus. Retrieved from https://www.raps.org/news-and-articles/news-articles/2019/4/ema-begins-safety-review-of-ms-drug-lemtrada
  17. U.S. Food & Drug Administration. (2018, November 29). FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-serious-risks-stroke-and-blood-vessel-wall-tears-multiple-sclerosis-drug
  18. Durand-Dubief, F., et al. (2015). Ischemic stroke with spontaneous multiple cervical artery dissections in a 40-y old woman during a first course of alemtuzumab: cause or coincidence? Multiple Sclerosis Journal. Retrieved from https://onlinelibrary.ectrims-congress.eu/ectrims/2015/31st/115247/francoise.durand-dubief.ischemic.stroke.with.spontaneous.multiple.cervical.html?f=m1
  19. Azevedo, C. J., et al. (2019, April). Intracerebral haemorrhage during alemtuzumab administration. The Lancet Neurology. Retrieved from https://www.thelancet.com/action/showPdf?pii=S1474-4422%2819%2930076-6
  20. American Stroke Association. (2018, October 2). Learn More Stroke Warning Signs and Symptoms. Retrieved from https://www.strokeassociation.org/en/about-stroke/stroke-symptoms/learn-more-stroke-warning-signs-and-symptoms
  21. U.S. Food & Drug Administration. (2018, November 29). FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-serious-risks-stroke-and-blood-vessel-wall-tears-multiple-sclerosis-drug