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