The multiple sclerosis drug Lemtrada (alemtuzumab) is under scrutiny from the European Medicines Agency (EMA), according to the drug regulator’s April 12, 2019 press release, “Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing”.
From this April 14, 2019 Medscape article, “PRAC Restricts Use of Alemtuzumab for MS Pending Ongoing Review”, we get these details about the latest drug safety issues associated with Lemtrada:
New reports of serious side effects affecting the heart, blood vessels, lungs, and liver of patients with relapsing-remitting multiple sclerosis (MS) who are taking [Lemtrada (alemtuzumab)] have prompted the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) to launch a review and to place temporary restrictions on use of the drug while the review is ongoing.
We reported previously that in November 2018 an FDA Drug Safety Communication was issued and there was a Lemtrada label change, which included an increased risk of strokes warning being added to the “Black-Box Warning” for Lemtrada.
We will continue to monitor drug regulatory actions regarding Lemtrada in the US, Europe, and elsewhere.[View article at original source]