Drug Injury Watch

Lemtrada Cardiovascular Reactions Can Occur Within 1-3 Days Of Infusions In People Without Any Identifiable Risk Factors

Unpredictable And Potentially Fatal Immune-Mediated Reactions Can Occur Within Months And Up To At Least 4 Years After Lemtrada Treatments

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has completed its review of Lemtrada (alemtuzumab) in the treatment of multiple sclerosis patients. Significant Lemtrada safety findings include the early risks of cardiovascular events with Lemtrada use and Lemtrada-related thrombocytopenia around the time of infusion, as well as long-delayed immune-mediated reactions involving Lemtrada years after its use.

The MHRA issued its review document, "Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions", on February 12, 2020. Here are its Lemtrada safety findings as regards the risks of cardiovascular events with Lemtrada use and immune-mediated reactions involving Lemtrada:

The review concluded that serious cardiovascular reactions can rarely occur within 1 to 3 days of [Lemtrada (alemtuzumab)] infusions in people without any identifiable risk factors. Reactions included myocardial ischaemia, cerebral haemorrhage, arterial dissection of the cervicocephalic arteries, pulmonary alveolar haemorrhage, and non-immune thrombocytopenia.

The review also found unpredictable and potentially fatal immune-mediated reactions can occur within months and up to at least 4 years after treatment with [Lemtrada (alemtuzumab)]. Reactions included autoimmune hepatitis, haemophagocytic lymphohistiocytosis, and acquired haemophilia A. The review also identified serious cases of Epstein-Barr virus reactivation reported after treatment, including hepatitis. Some patients developed more than one autoimmune disorder following treatment.

Lemtrada is a monoclonal antibody (mAb) authorized for the treatment of adults with relapsing-remitting multiple sclerosis.

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We have written several times previously about Lemtrada safety findings pointed out by the FDA and other drug regulatory agencies in the past couple of years:

• In December 2018 we published this article, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label", which covered a November 2018 FDA Drug Safety Communication about Lemtrada.
• In July 2019 we published this article, "Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation", to inform the MHRA had established new use restrictions and requiring increased monitoring of patients using this Lemtrada.
• In October 2019 we published this article, "Lemtrada Adverse Events May Occur More Frequently Than Previously Noted By Drug Safety Regulators And Researchers", which pointed out a study that found six additional deaths related to Lemtrada use that had not been reported before.

Soon after that last article, a "Dear Healthcare Professional Letter" was sent out by sanofi-aventis Canada Inc., "LEMTRADA (alemtuzumab) - Risk of Autoimmune Hepatitis, Haemophagocytic Lymphohistiocytosis, and Associated Serious Cardiovascular Reactions".

We will continue to monitor the medical literature for reports of cardiovascular events with Lemtrada use and immune-mediated reactions involving Lemtrada.

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)

Lemtrada Use Restrictions Issued By EMA’s Pharmacovigilance Risk Assessment Committee Due To Safety Issues

Action Due To Reports Of Lemtrada Side Effects Including Deaths Related To Immune Complications And Heart Or Circulatory Disorders

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In late October 2019 the Pharmacovigilance Risk Assessment Committee (PRAC) -- a part of the European Medicines Agency (EMA) -- issued its final Lemtrada drug safety recommendations for use in relapsing-remitting multiple sclerosis (RRMS). The bottom line is PRAC advises that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada.

For the details, we look to this November 5, 2019 Multiple Sclerosis News Today report, "EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs":

Specifically, reports of fatalities and severe effects were associated with immune complications that included autoimmune hepatitis (immune-caused liver damage) and hemophagocytic lymphohistiocytosis (a disorder that may affect several organs in the body), and hemolytic anemia (abnormal red cell breakdown). Some immune reactions could happen “many months” after treatment with Lemtrada, PRAC noted.

Reports also surfaced of severe and deadly heart, circulation, and bleeding disorders, including heart attack, stroke, bleeding in the lungs, and cervicocephalic arterial dissection (tears in the arteries from the head and neck). These adverse events, PRAC said, could develop within days of Lemtrada’s use.

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From the first part of an EMA document titled "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2019", here is a summary of the PRAC Lemtrada restrictions proposal:

EMA’s safety committee (PRAC) recommended restricting Lemtrada for use in adults with relapsing remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy or if the disease is worsening rapidly with at least two disabling relapses in a year and brain-imaging showing new damage.

We have written about Lemtrada safety issues three times previously over the past twelve months:

• "Lemtrada Adverse Events May Occur More Frequently Than Previously Noted By Drug Safety Regulators And Researchers" (October 9, 2019)
• "Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation" (July 3, 2019)
• "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label" (December 4, 2018)

We will watch for more Lemtrada drug safety developments in the medical and regulatory realms while we continue to investigate possible drug injury cases for patients seeking legal compensation for serious side effects.

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)

Lemtrada: Reports Of Serious Cardiovascular Events And Immune-Mediated Reactions Under Investigation

UK Drug Safety Regulator MHRA Imposes Lemtrada Use Restrictions And Mandates Patient Monitoring For Side Effects

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In May 2019 the UK's Medicines and Healthcare products Regulatory Agency (MHRA) took regulatory action regarding Lemtrada establishing new use restrictions and requiring increased monitoring of patients using this multiple sclerosis (MS) drug.

From the introductory part of this May 17, 2019 MHRA Drug Safety Update, "Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements", we get this summary:

While an urgent [European Union (EU)] safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. All patients on alemtuzumab for multiple sclerosis should be alerted to these risks and what to do if symptoms occur.

For some background on the EU safety review of Lemtrada mentioned above, we refer you to our April 2019 article "Lemtrada Review By European Drug Regulatory Agency Covers Various Serious Side Effects In MS Patients".

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Returning to the May 2019 Lemtrada Drug Safety Update from the UK's MHRA, we have compiled this list of serious side effects which have been reported in MS patients using Lemtrada "particularly within 3 days of dosing":

Cases of cardiovascular reactions

• Pulmonary hemorrhage
• Myocardial infarction
• Arterial dissection
• Stroke (hemorrhagic and ischemic)

Cases of immune-mediated disorders

• Autoimmune hepatitis
• Hemophagocytic lymphohistiocytosis

We will continue to watch for reports of serious cardiovascular events and immune-mediated reactions involving Lemtrada.

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)