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New safety measures for Alemtuzumab approved

Recommendations from the European Medicines Agency (EMA) have been finalised, after a review into the safety of alemtuzumab (brand name Lemtrada) was completed.
The EMA says alemtuzumab should continue to be offered to treat MS and has introduced new measures to keep the risk of serious side effects as low as possible.

Why did the EMA review alemtuzumab?

The EMA were responding to reports of side effects affecting the heart, blood vessels, liver and immune system, and launched a safety review in April 2019. These side effects are rare but can be serious.

What are the new safety measures?

The EMA has said people should carry on being offered alemtuzumab if their MS is still highly active after taking another DMT.

It says alemtuzumab should only be offered as a first treatment to those who’ve had two relapses in the last year, and MRI scans that show new signs that their MS is active (new lesions). This is slightly more restrictive than previously, but people are rarely offered alemtuzumab as their first DMT.

It also says alemtuzumab must no longer be prescribed to people with certain heart, circulation or bleeding disorders, or in people who have auto-immune disorders other than MS.

As part of its steps to make the risk as low as possible, it also recommends that people are given alemtuzumab in a hospital.

What does this mean for people with MS?

People being treated with alemtuzumab and benefiting from it can continue taking the treatment.

But you may not be able to continue taking alemtuzumab if you have a heart condition, circulation or bleeding disorder or an auto-immune disorder other than MS.

If you’re unsure how this will affect you, or you're experiencing any unexpected side effects, you should speak to your neurologist as soon as possible.

What next?

Doctors across the UK who prescribe alemtuzumab will now have to follow the new measures, which apply from January 2020.

You can read more about the recommendations on the European Medicine Agency's website.

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