What is Lemtrada?
Lemtrada is a prescription medication used to treat patients who suffer from relapsing forms of multiple sclerosis (MS). According to the drug’s prescribing information sheet, the use of Lemtrada should generally be reserved for patients who have tried at least two or more drugs to treat MS and who have had an inadequate response. Lemtrada is administered by intravenous infusion.
FDA Warning Involving Lemtrada
On November 29, 2018, the U.S. Food and Drug Administration (FDA) issued a safety announcement “warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab).” According to the FDA, these problems can possibly lead to “permanent disability and even death.”
Since the FDA approved Lemtrada in 2014, 13 cases of ischemic and hemorrhagic stroke or arterial dissection have been identified. Twelve cases reported symptoms within one day of receiving the treatment.
Other Serious Side Effects of Lemtrada
Other serious side effects associated with the use of Lemtrada may include:
- serious autoimmune problems, including immune thrombocytopenia and anti-glomerular basement membrane disease;
- serious infusion reactions that may cause death; and
- certain cancers, including thyroid cancer, skin cancer (melanoma), and certain blood cancers (lymphoproliferative disorders and lymphoma).
Other serious health risks associated with the use of Lemtrada may include thyroid problems, low blood counts serious infections, inflammation of the gall bladder without gallstones (acalculous cholecystitis), and swelling of lung tissue (pneumonitis).
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Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
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