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EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of Uptravi (selexipag), following the deaths of 5 patients taking the medicine in France. Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, but use must be in line with the current prescribing information.

The PRAC will further explore all available data. Once the review is completed, final conclusions will be published.

More information:

EMA reviewing safety of Uptravi for pulmonary arterial hypertension (updated)

 
Information for citizens

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is warning that an increase in cases of lower limb amputation (mostly affecting the toes) has been observed in patients taking the type 2 diabetes medicine canagliflozin compared with those taking placebo (a dummy treatment) in two clinical trials, CANVAS and CANVAS-R. The studies, which are still ongoing, involved patients at high risk of heart problems.

More information on the following link:

PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation

 
Information for citizens

EMA to review certain injectable medicines to treat allergy

Risks of some methylprednisolone products in patients allergic to cows' milk proteins to be investigated

The European Medicines Agency (EMA) has started a review of certain medicines given by injection to treat severe, rapidly developing (acute) allergic reactions. The medicines involved contain the corticosteroid methylprednisolone as active ingredient. They also include as an additional ingredient lactose (milk sugar), which potentially contains traces of cows' milk proteins that could affect treatment of acute reactions in the small number of highly sensitive patients allergic to these proteins.

More information:

Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

 
Information for citizens

PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C

Review of liver cancer risk not conclusive and further studies are needed

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that patients treated with medicines known as direct-acting antivirals for hepatitis C may be at risk of hepatitis B re-activation. As a result of this review, the PRAC has recommended that, before starting treatment, all patients should be screened for hepatitis B virus; those patients co-infected with hepatitis B and C viruses must then be monitored and managed according to current clinical guidelines.

More information:

PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C

 
Information for medical specialists

Effectiveness of measures for pregnancy prevention and for minimising possible risk of neuropsychiatric disorders to be evaluated

The European Medicines Agency (EMA) has started a review of retinoid medicines to evaluate measures currently in place for pregnancy prevention and for minimising the possible risk of neuropsychiatric disorders.

Retinoids (which include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin) are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.

More information on:

Retinoid-containing medicinal products

 
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