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Alemtuzumab (Lemtrada®) under safety review by European Medicines Agency

15 April 2019

Alemtuzumab (Lemtrada®), one of the approved treatments for relapsing MS in Australia, is being reviewed as a first line therapy by regulatory bodies overseas. The European Medicines Agency (EMA) has started a safety review of alemtuzumab based on new reports overseas of rare but potentially serious side effects affecting the heart, blood vessels, liver and immune system.

The Australian sponsor of alemtuzumab has notified the Australian regulatory body, the Therapeutic Drugs Administration (TGA) of all relevant safety information and this is being evaluated. This may result in an update to prescribing information that will be made available to doctors and healthcare professionals involved in the prescription of alemtuzumab in Australia. The TGA has not announced a full safety review at this stage. It is expected the international review will take up to six months.

The EMA has advised people who are already being treated with alemtuzumab, and finding it beneficial, to continue on the medication. However, new prescriptions in Europe are being limited and may only be provided to people who are not responding to other therapies.

Side effects may include sudden heart problems such as trouble breathing and chest pain, coughing up blood, drooping of the face, sudden severe headache, weakness on one side, difficulty with speech, neck pain, a yellowing of skin or eyes, dark urine, bleeding or bruising more easily than normal, fever, swollen glands, bruising and skin rash.

If you have been treated with alemtuzumab and experience any of the symptoms above or have any concerns please speak to your neurologist or members of your medical team.

New reports of side effects relating to blood vessels and strokes prompted the US regulatory body, the Food and Drug Administration (FDA) to issue a new warning about alemtuzumab in November 2018 (see here for more information).

More information about the EMA review can be found here.