Ten Deaths Identified As Being Most Probably Related To Lemtrada, With Six Of These Cases Not Previously Reported, According To New Study
UPDATE: "Dear Healthcare Professional Letter" sent October 15, 2019 by sanofi-aventis Canada Inc.: LEMTRADA (alemtuzumab) - Risk of Autoimmune Hepatitis, Haemophagocytic Lymphohistiocytosis, and Associated Serious Cardiovascular Reactions
Lemtrada adverse events have been on our radar for about the past year, and now there is some new drug safety information about Lemtrada use to report.
Back in December 2018 we published this article, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label". It covered this November 2018 FDA Drug Safety Communication, "FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)"
Then in July 2019 we posted this article, "Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation", to inform the UK's Medicines and Healthcare products Regulatory Agency (MHRA) had taken regulatory action in May 2019 regarding Lemtrada. Specifically, the MHRA established new use restrictions and requiring increased monitoring of patients using this multiple sclerosis (MS) drug.
Now we are learning fatal adverse events (AEs) associated with Lemtrada may occur more frequently than previously understood, according to medical researchers.
Strictly Confidential, No Obligation.
This finding by those researchers was published in this medical journal article, "Adverse events with fatal outcome associated with alemtuzumab treatment in multiple sclerosis", published August 12, 2019 by BMC Research Notes. From the Abstract for this recent Lemtrada study report we get the following:
Results: We identified nine cases with a probable and one case with a possible causal relationship between [Lemtrada (alemtuzumab)] treatment and a fatal adverse event. Six of these patients died within one month after treatment; one from intracerebral hemorrhage, two from acute multiple organ failure and septic shock, one from listeriosis, one from pneumonia and one from agranulocytosis. Four patients died several months after administration of [Lemtrada (alemtuzumab)] from either autoimmune hepatitis, immune-mediated thrombocytopenia, autoimmune hemolytic anemia or agranulocytosis. Four of the 10 cases had been published previously in case reports or congress abstracts. Fatal adverse events related to treatment with [Lemtrada (alemtuzumab)] occur more frequently than previously published in the literature. A significant proportion occurs in the first month after treatment.
The underlying Lemtrada study is discussed in this August 29, 2019 piece, "Link Between Lemtrada, Mortality More Common Than Previously Reported", found on the Multiple Sclerosis News Today web site. When this piece was viewed on October 9, 2019 there were six Comments posted, including some from and about actual MS patients who used Lemtrada and experienced apparent adverse events.
Of course, we will continue to monitor the drug safety profile of Lemtrada in the US and Europe. If you have any Lemtrada adverse events or other relevant information which you would like to share, you can submit a Comment below.
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligation. (Case review is done by attorney Tom Lamb)