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Saxenda▼ (liraglutide) - patient safety update

Saxenda▼, for Type 2 diabetes, Diabetic ketoacidosis and Obesity from Novo Nordisk Ltd

Novo Nordisk, the manufacturers of weight loss treatment liraglutide, brand name Saxenda▼, have warned that following a drug safety update, that patients taking Saxenda who have type 2 diabetes mellitus, liraglutide must not be used as a substitute for insulin.

They report that diabetic ketoacidosis has been reported in insulin dependent patients after rapid discontinuation or dose reduction of insulin.

Diabetic ketoacidosis (DKA) is a serious problem that can occur in people with diabetes if their body starts to run out of insulin.

This causes harmful substances called ketones to build up in the body, which can be life-threatening if not spotted and treated quickly.

Signs of DKA include:
  • needing to pee more than usual
  • feeling very thirsty
  • being sick
  • tummy pain
  • breath that smells fruity (like pear drop sweets or nail varnish)
  • deep or fast breathing
  • feeling very tired or sleepy
  • confusion
  • passing out
DKA can also cause high blood sugar (hyperglycaemia) and a high level of ketones in your blood or urine, which you can check for using home-testing kits.

Symptoms usually develop over 24 hours, but can come on faster.

You can follow developments with Saxenda by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About Saxenda (source EMA)
Saxenda is a medicine used along with diet and exercise to help manage weight in adults:
  • who are obese (have a body-mass index – BMI – of 30 or more);
  • who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep).
BMI is a measurement that indicates body weight relative to height.

The active substance in Saxenda, liraglutide, is a ‘glucagon-like peptide-1 (GLP-1) receptor agonist’ that is already authorised in the EU as Victoza at lower doses (up to 1.8 mg per day) for the treatment of type 2 diabetes.

The exact way that Saxenda works in weight loss is not fully understood, but it appears to act on the parts of the brain that regulate appetite, by attaching to GLP-1 receptors in brain cells and thereby increasing feelings of fullness and lowering feelings of hunger.

Saxenda was first made available in the EU in 2015. It is manufactured by Novo Nordisk.

Sources
European Medicines Agency website page for Saxenda
Summary of product characteristics
NHS website for diabetic ketoacidosis
Contains public sector information licensed under the Open Government Licence v3.0.
Accessed 09/08/19
Links available in External Resources

EMA information on Saxenda

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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