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Patients with active infection with this virus should not be treated with ofatumumab.
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Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine.
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New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction.
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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Cases of intraoperative floppy iris syndrome (IFIS) during cataract surgery have been reported in patients taking the atypical antipsychotics risperidone or paliperidone.
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It is essential that the entire contents of the solvent vial is added to the concentrate vial to produce a concentrate-solvent mixture with the intended concentration of 10 mg/mL cabazitaxel.
It is essential that the enti…
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Not for use in pregnancy unless there is no effective alternative.
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Use has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review.
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A recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks.
To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in…
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Different antiepileptic drugs (AEDs) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss…
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Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines.
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Clarification of advice on new recommendations regarding initial test dose.
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Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; it has also been reported …
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Importance of establishing wildtype RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer.
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Public consultation launched on the continued availability of oral diclofenac as a pharmacy (P) medicine and on risk-minimisation measures advised by the Commission on Human Medicines.
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Restricted dose and duration of use.
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All products to be named and prescribed as caffeine citrate.
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New strengthened recommendations to manage and minimise risk.
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New advice on dilution and administration in patients age 65 years or older refers only to the indication for prevention of chemotherapy-induced nausea and vomiting.
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Reports of pigment changes in ocular tissue, skin, lips or nails.
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Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone.
Furthermore, a significant risk of se…
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New specific guidance on dose-dependent prolongation of QTc with ondansetron.
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Strengthening surveillance of medicines throughout the EU
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The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Programme (PPP), which is s…
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Updated prescribing advice provided.
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Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids.
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New recommendations after a Europe-wide review of cardiovascular safety.
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Remember to report any suspected adverse reactions
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Recent interruption to the supply of liothyronine 20 microgram tablets from Amdipharm Mercury.
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liver-function testing recommended in patients with symptoms that may indicate liver injury.
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Healthcare professionals should consider this risk when deciding whether to treat patients with thalidomide monitor for the occurrence of these conditions.
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Care needed to minimise risk of error, including training for patients.
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Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines
Furthermore, cilostazol is now contraindicated in patients with any of the following:
Unstable ang…
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Please be vigilant as life-threatening errors may occur
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Risks such as toxin spread reported mostly with off-label use.
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May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
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Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
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Updated guidance on minimising risk of life-threatening and fatal air embolism.
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Rare cases of atypical femoral fracture with long-term use.
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Routine monitoring of liver function now recommended.
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Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.
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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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Preliminary HPS2-THRIVE trial failed to show benefit outweighs risks
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Safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
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Risk of serious skin-related adverse drug reactions, including Stevens-Johnson syndrome, occurring with carbamazepine may be increased in the presence of the HLA-A*3101 allele in patients of European descent or Japanese orig…
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The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.
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A safety review conducted at the end of its routine use during the ongoing human papillomavirus immunisation programme has found that no new risks have been identified for Cervarix, and that the balance of its risks and bene…