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Information for citizens

The European Medicines Agency (EMA) has started a review of the multiple sclerosis medicine Tysabri (natalizumab). The aim of the review is to assess whether the advice given to healthcare professionals and patients on how to manage the known risk of progressive multifocal leukoencephalopathy (PML) with this medicine should be revised in the light of new scientific evidence.

PML is a rare brain infection caused by John Cunningham virus (JCV), which has symptoms that may be similar to those of a multiple sclerosis attack, and may result in severe disability or death. It is already known that the risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than two years. The risk of PML is also higher if the patient used immunosuppressant medicines (medicines that reduce the activity of the immune system) before starting Tysabri, or if the patient has tested positive for antibodies against the virus that causes PML (a sign that the virus may be present in the body).

Scientific evidence on PML is rapidly growing. New data seem to indicate that the methods used to calculate the risk of PML may need to be revised and that testing for PML in patients with no symptoms may need to be performed more frequently than currently recommended. New diagnostic tests have recently been developed and there is a need to assess whether this has an impact on the current prescribing advice.

EMA will now evaluate the available data on the risk of PML with Tysabri with the aim of better defining the risk of PML and identifying further measures to minimise it, and will issue an opinion on whether changes to the marketing authorisation are needed.

More information is provided in the following hyperlink:

EMA, Tysabri

 
Information for citizens

Review confirms small increased cardiovascular risk with daily doses at or above 2,400 mg

European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day).

The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

More information is provided in the following hyperlink:

PRAC recommends updating advice on use of high-dose ibuprofen

 
Information for medical specialists

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.

The PRAC recommended specifically that:

  • Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
  • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
  • All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.

The effects of codeine are due to its conversion into morphine in the body. Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood. High levels of morphine can lead to serious effects, such as breathing difficulties.

Read more on the following hyperlink:

PRAC recommends restrictions on the use of codeine for cough and cold in children

 
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