Parker Waichman LLP

FDA Releases Stroke Alert, Adding to Lemtrada Side Effects

Multiple sclerosis (MS) is a varied, debilitating condition, with differing symptoms and pathology. On Nov. 29th, the Food and Drug Administration (FDA) released a safety announcement warning that warned that not all MS treatment drugs are equal. Alemtuzumab, commercially known as Lemtrada, may be linked to serious health risks resulting in a stroke or other […]

Multiple sclerosis (MS) is a varied, debilitating condition, with differing symptoms and pathology. On Nov. 29th, the Food and Drug Administration (FDA) released a safety announcement warning that warned that not all MS treatment drugs are equal. Alemtuzumab, commercially known as Lemtrada, may be linked to serious health risks resulting in a stroke or other dangerous complications.

What is Lemtrada?

Lemtrada is a drug designed to manage MS that worsens for a short period before returning to base levels, also known as relapsing MS. The intravenously administered medication is used to target MS that displays resistance to other treatments.

Lemtrada was approved in 2014 by the FDA. Since that approval, the drug has been linked to 13 cases of ischemic or hemorrhagic stroke, as well as arterial dissection. The FDA believes that “the occurrence of these adverse events within one day of Lemtrada administration suggests an association,” according to the safety announcement.

Common Lemtrada Side Effects

As stated in the FDA report, Lemtrada’s side effects occur most often one day after beginning treatment. However, there have been reports of symptoms taking as long as three days to appear. The complication that prompted the FDA’s safety announcement is known as cervicocephalic arterial dissection.

The condition wears down and tears arteries located in the skull or in the neck. While arterial tears are significant injuries anywhere in the body when arteries rip in the head or neck, they can lead to strokes.

Ischemic strokes may occur because the blood is not reaching vital areas of the brain, causing those areas to die of malnutrition. Additionally, hemorrhagic strokes can arise from blood hemorrhaging into the brain and causing undue swelling or pressure to build up in various regions of the brain.

The FDA advises prevention of these complications by remaining vigilant for any of the following symptoms:

  • Abrupt Numbness or weakness in the face, arms, or legs
  • Confusion
  • Loss of balance or coordination
  • Trouble communicating
  • Difficulty comprehending speech
  • Sudden vision issues with either one or both eyes
  • Difficulty with walking
  • Dizziness
  • Sudden severe headache or neck pain

Even reporting of less specific symptoms such as neck pain or a headache can potentially lead to a lifesaving diagnosis through further testing.

Who is at risk for Lemtrada side effects?

Anyone who takes Lemtrada may be at risk for these rare complications. Other individuals who may be at risk, according to the FDA, are individuals who take alemtuzumab for management of B-cell chronic lymphocytic leukemia (B-CLL) as Campath.

Lemtrada Side Effects Lawyers

The FDA advises all patients taking Lemtrada to seek emergency medical attention if they experience an ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. If you or a loved one has suffered because of medical negligence, and Lemtrada was prescribed without exploring other avenues of treatment first, leading to stroke or other lifelong injuries, you may be entitled to financial compensation.

Contact Parker Waichman LLP if you believe you or a loved one experienced Lemtrada side effects.


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