EMA to review modified-release paracetamol
Measures to minimise risk and reduce harm of overdose to be considered
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EMA reviews diabetes medicine canagliflozin
Review follows data on toe amputations in ongoing study
The European Medicines Agency (EMA) has started a review of the diabetes medicine canagliflozin after an increase in amputations, mostly affecting toes, was observed in an ongoing clinical trial called CANVAS. Cases of lower limb amputation occurred in both the canagliflozin and placebo groups in the trial and the possibility that canagliflozin increases lower limb amputations is currently not confirmed. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from the company to assess whether canagliflozin causes an increase in lower limb amputations and whether any changes are needed in the way this medicine is used in the EU.
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Review to consider evidence on gadolinium accumulation in brain tissue
The European Medicines Agency (EMA) has started a review of the risk of gadolinium deposition in brain tissue following the use of gadolinium contrast agents in patients having magnetic resonance imaging (MRI) scans.
Gadolinium contrast agents are diagnostic products that may be given to patients before or during MRI scans to help doctors obtain better images of organs and tissues. After administration, gadolinium agents are mostly eliminated via the kidneys but studies indicate that deposits can build up in some body tissues, including in the liver, kidney, muscle, skin and bone.
Read more: EMA reviewing gadolinium contrast agents used in MRI scans
Review to consider evidence on gadolinium accumulation in brain tissue
The European Medicines Agency (EMA) has started a review of the risk of gadolinium deposition in brain tissue following the use of gadolinium contrast agents in patients having magnetic resonance imaging (MRI) scans.
Gadolinium contrast agents are diagnostic products that may be given to patients before or during MRI scans to help doctors obtain better images of organs and tissues. After administration, gadolinium agents are mostly eliminated via the kidneys but studies indicate that deposits can build up in some body tissues, including in the liver, kidney, muscle, skin and bone.
Read more: EMA reviewing gadolinium contrast agents used in MRI scans
Review to investigate possible hepatitis B re-activation
The European Medicines Agency (EMA) has started a review of medicines known as direct-acting antivirals used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Read more: EMA reviews direct-acting antivirals for hepatitis C
Measures include close monitoring and use of antibiotics to prevent pneumonia
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible. Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).
Measures include close monitoring and use of antibiotics to prevent pneumonia
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible. Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has finalised a review of SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations to minimise the risk of diabetic ketoacidosis. Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes and a number of these cases have been atypical, with patients not having blood sugar levels as high as expected. Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.
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EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of the risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab) and has recommended new measures to minimise this risk. PML is a rare and very serious brain infection caused by John Cunningham (JC) virus. New advice may help early detection of PML and improve patients’ outcomes.
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- Review concludes evidence does not support that HPV vaccines cause CRPS or POTS
- Start of review of nasal and mouth sprays containing fusafungine
- Review of diabetes medicines called SGLT2 inhibitors started
- PRAC recommends updating advice on use of high-dose ibuprofen
- PRAC recommends restrictions on the use of codeine for cough and cold in children
- PRAC recommends restrictions on the use of codeine for cough and cold in children
- PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses, with new restrictions
- PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)
- PRAC recommends strengthening the restrictions on the use of valproate in women and girls Women to be better informed of the risks of valproate use during pregnancy
- PRAC review does not confirm increase in heart problems with testosterone medicines Committee recommends medicines can continue to be given for their authorised uses
