Drug safety advice
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Tolvaptan (Samsca▼): risk of liver injury—liver-function testing recommended in patients with symptoms that may indicate liver injury
Drug-induced liver injury has been observed in clinical trials investigating potential use in patients with autosomal dominant polycystic kidney disease (ADPKD, an unlicensed indication) at higher doses than those for the approved indication and in long-term use. Liver-function tests should be done in patients taking tolvaptan who report signs or symptoms that suggest liver injury.
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Thalidomide: risk of second primary malignancies
Patients treated with thalidomide have an increased risk of haematological second primary malignancies (acute myeloid leukaemia and myelodysplastic syndromes). Healthcare professionals should consider this risk when deciding whether to treat patients with thalidomide, and should monitor for the occurrence of these conditions
Yellow Card Scheme update
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Black Triangle (▼) medicines now part of an EU-wide scheme: remember to report any suspected adverse reactions
Although the Black Triangle (▼) has been in place in the UK for many years to signify medicines that are subject to intensive monitoring, it will now also be used in all EU countries and this list of medicines has been agreed Europe-wide. Throughout Europe, this scheme is known as ‘additional monitoring’.
Stop Press
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Liothyronine 20 microgram tablets: continuity of supply and potential need for patient monitoring
There has been a recent interruption to the supply of liothyronine 20 microgram tablets from Amdipharm Mercury.
As a result of this current unavailability, patients taking this medicine may have had their prescription filled by an unlicensed product (imported from the EU) under the direct personal responsibility of a prescriber. The interchangeability of Amdipharm Mercury liothyronine tablets with liothyronine tablets that are not currently licensed in the UK cannot be assured because they may not be bioequivalent.