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New safety measures for Alemtuzumab

The European Medicines Agency (EMA) has published recommendations from its review into the safety of alemtuzumab (brand name Lemtrada).

The EMA recommended alemtuzumab should continue to be offered to treat MS and 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 could be serious.

What are the new safety measures?

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

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

It also recommends alemtuzumab must no longer be used by 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?

Until the recommendation comes into force in January 2020, 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 are experiencing any unexpected side effects, you should speak to your neurologist as soon as possible.

What next?

The recommendations of the safety review will be formally adopted by the Committee for Medicinal Products for Human Use (CHMP) soon.

Doctors across the UK who prescribe alemtuzumab will then have to follow the recommendations, which will start to apply in January 2020.

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

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