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Several new high strength insulin products are now on the market. The European Medicines Agency is consulting on guidance to minimise the risk of medication error.
If pioglitazone is used in combination with insulin patients should be observed for signs and symptoms of heart failure, weight gain, and oedema.
(Novartis Vaccines and Diagnostics GmbH) Potential problem with packaging of the syringes supplied with specific batches of Rabipur – class 4 caution in use. (EL (12)A/13)
Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
The CMA is investigating alleged excessive and unfair prices with respect to hydrocortisone tablets under Chapter II CA98/ Article 102 TFEU.
In view of reports of serious bleeding events in patients taking miconazole and warfarin, we are considering further measures to minimise the risk of potentially serious interactions between miconazole and warfarin.
Use restricted to adults with advanced or metastatic breast cancer only.
Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
A summary of letters and drug alerts recently sent to healthcare professionals.
Switching from posaconazole oral solution to tablets has resulted in cases of dose-related toxicity, whereas switching from tablets to oral solution has resulted in underdosing and lack of efficacy.
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 patients with active or a...
Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
Alliance Pharmaceuticals Ltd has informed the MHRA that there are possible side effects not reported on the Patient Information Leaflet.
The authorised dose regimen for N-acetylcysteine (NAC) in paracetamol overdose is 3 consecutive bags given intravenously over 21 hours. Prescribing information is being updated to advise that continued treatment with NAC may be necessary depending on clinical evaluation of the...
Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel), and telavancin (Vibativ▼).
A summary of safety letters sent to healthcare professionals in August 2016
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