EMA Will Investigate Reports Of Associated Conditions Beyond Those That Were In November 2018 FDA Drug Safety Communication
We recently learned by means of this April 12, 2019 European Medicines Agency (EMA) press release, "Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing", that the multiple sclerosis (MS) drug Lemtrada (alemtuzumab) is facing more scrutiny from drug regulators.
As background, we reported in this December 4, 2018 post, "Lemtrada: Warnings About Strokes And Arterial Dissections / Blood Vessel Lining Damage Added To Drug Label", 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.
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.
In addition to the restrictions, PRAC has recommended an update of the product information for [Lemtrada (alemtuzumab)] to inform patients and healthcare providers about cases of immune-mediated conditions, including autoimmune hepatitis and hemophagocytic lymphohistiocytosis; problems with the heart and blood vessels that occur within 1 to 3 days of treatment, including bleeding in the lungs, heart attack, stroke, and cervicocephalic arterial dissection; and severe neutropenia.
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Returning to the April 2019 EMA press release about their Lemtrada safety investigation, we get the following from the "Information for patients" section:
- New cases of side effects have been reported with Lemtrada, including some affecting the heart, blood vessels, lungs and liver.
- You should get medical help immediately if you experience symptoms of:
-- acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
-- bleeding in lungs: such as trouble breathing and coughing up blood
-- stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain
-- liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
-- an inflammatory condition known as haemophagocytic lymphohistiocytosis: such as fever, swollen glands, bruising and skin rash.
Looking forward, the PRAC’s final recommendations about Lemtrada will be forwarded to the Committee for Medicinal Products for Human Use (CHMP) for their consideration.
We will continue to monitor drug regulatory actions regarding Lemtrada in the US, Europe, and elsewhere.
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