Annauncements / «Information for medical specialists»
PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations Review finds evidence of gadolinium deposits in the brain after MRI body scans but no signs of harm
EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for four linear gadolinium contrast agents because of evidence that small amounts of the gadolinium they contain are deposited in the brain.
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.
PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation Risk may also apply to other medicines in the same class
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.
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Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
Recommendations for patients with kidney impairment updated in product information
The European Medicines Agency (EMA) has concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate]=30–59 ml/min) for the treatment of type 2 diabetes. The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
The recommendations are the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function. The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.
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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).Read more...
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...
Risk of diabetic ketoacidosis to be examined
The European Medicines Agency (EMA) has started a review of canagliflozin, dapagliflozin and empagliflozin, which are medicines known as SGLT2 inhibitors used to treat type 2 diabetes. The aim of the review is to evaluate the risk of diabetic ketoacidosis, a serious condition that usually develops in people with type 1 diabetes when insulin levels are too low.
The review of SGLT2 inhibitors has been requested by the European Commission following reports1 of diabetic ketoacidosis in patients on SGLT2 inhibitor treatment for type 2 diabetes. All cases were serious and some required hospitalisation. Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.
EMA will now review all available data on the risk of diabetic ketoacidosis with SGLT2 inhibitors and consider whether any changes are needed in the way these medicines are used in the EU.
PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small.
Update of product information is recommended
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine. This follows concerns over the risk of allergic reactions with these medicines, which are widely used as expectorants (to help clear mucus from the airways).
The PRAC considers that the risk of allergic reactions is small, but has recommended that the product information for these medicines should be updated with further information on severe allergic reactions, and that severe skin reactions (SCARs) should be introduced as a side effect. SCARs include conditions such as erythema multiforme and Stevens-Johnson syndrome.
Start of review of codeine-containing medicines when used for cough and cold in children
PRAC recommends restricting use of codeine when used for pain relief in children
The PRAC has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
Review of hydroxyzine-containing medicines started
The European Medicines Agency has started a review of hydroxyzine-containing medicines, which have been approved in most EU countries for a variety of uses including anxiety disorders, as premedication before surgery, for relief of pruritus (itching), and for sleep disorders.
Review of testosterone-containing medicines started
The European Medicines Agency has started a review of testosterone-containing medicines, mainly used in men who do not produce enough testosterone (a condition known as hypogonadism).
Review of Corlentor/Procoralan started
The European Medicines Agency has started a review of the medicine Corlentor/Procoralan (ivabradine). Corlentor/Procoralan is used to treat the symptoms of adults with long-term stable angina (chest pain due to obstruction in the arteries in the heart) or long-term heart failure (when the heart cannot pump enough blood to the rest of the body).
Start of review of ambroxol and bromhexine-containing medicines
The European Medicines Agency has started a review of medicines containing ambroxol and bromhexine, which are widely used as expectorants, as well as to relieve sore throat. Some formulations are used to treat breathing disorders in premature and newborn babies.
Review of oral methadone medicines containing povidone started
The European Medicines Agency has started a review of oral (by mouth) methadone medicines that also contain povidone. Methadone-containing medicines are used in rehabilitation programs in patients dependent on opioids, such as heroin, to prevent or reduce withdrawal symptoms in order to decrease the chance of relapse.
PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the risks of combining different classes of medicines that act on the renin-angiotensin (RAS) system, a hormone system that controls blood pressure and the volume of fluids in the body.
CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem
European Commission to take final legal decision
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed by majority new recommendations for zolpidem-containing medicines, used for the short-term treatment of insomnia (difficlty sleeping).
PRAC recommends restricting use of domperidone
Benefits still considered to outweigh risks when given short-term and in low doses to treat nausea or vomiting.
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