The FDA has issued a warning about potential stroke and tears in the lining of head and neck arteries, which occurred in some patients after receiving Lemtrada (alemtuzumab, Genzyme). Stroke and tears can potentially lead to permanent disability and even death. The agency has added a new warning about these risks to the drug’s prescribing information and the patient medication guide, and it has also added the risk of stroke to the existing boxed warning.
Alemtuzumab is also available as Campath, which was approved in May 2001 for treating B-cell chronic lymphocytic leukemia (B-CLL). The Campath label will also be changed to include these risks in the adverse reactions section.
Health care professionals are advised to tell patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. As early symptoms such as headache and neck pain are not specific, diagnosis can be complicated. Prompt evaluation of patients who complain of symptoms that are consistent with stroke or arterial dissection is recommended.
Most patients who developed stroke or tears in their artery linings had symptoms within one day of being treated with alemtuzumab.
Source: Drugs.com, November 28, 2018