The FDA is warning that it has received a small number of serious reports of stroke and tears in the lining of head and neck arteries in patients taking the multiple sclerosis (MS) drug Lemtrada (alemtuzumab).
The agency has received reports of 14 such cases since Lemtrada was approved for MS in 2014. Most of the serious effects occurred within one day of receiving the drug. The problems “can lead to permanent disability and even death,” according to the FDA.
As a result, the new risks will be added to Lemtrada’s drug label with the stroke risk added to an existing “black box” warning, the agency’s most serious. Alemtuzumab is also approved under the name Campath as a leukemia treatment, and its label will also get the same changes.
The FDA says that patients should seek emergency treatment immediately if they experience signs or symptoms of artery lining tears or stroke, such as sudden numbness or weakness in the face, arms or legs; sudden confusion or trouble speaking; sudden vision problems; sudden difficulty walking or maintaining balance; and sudden severe head or neck pain.
Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.