Letters and drug alerts sent to healthcare professionals in November 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
From:
Therapeutic area:
Please see our website for updated information for healthcare professionals and the public.
Letters
Drug alerts
Class 4 Medicines Defect Information, Kolanticon Gel 200ml, (PL 17509/0084), EL (20) A/51. Issued 9 November 2020. For one batch of this product, there is a difference in dosage instructions between the carton and label – the Patient Information Leaflet (PIL) and bottle label contain the correct instructions. When dispensing or providing this product, please check batch number and ensure that patients are aware of the correct dosing instructions.
Advice for healthcare professionals:
an increased risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy has been reflected in the product information for some time
data from three recent meta-analyses has led to updates for the magnitude of increased risk with erythromycin use during infancy in general, and to reflect that the risk is highest in the first 14 days after birth
consider the benefit of erythromycin therapy against the potential risk of developing infantile hypertrophic pyloric stenosis
advise parents to seek advice from their doctor if vomiting or irritability with feeding occurs in infants during treatment with erythromycin
Advice for healthcare professionals:
be aware of reports of cardiotoxicity (QT interval prolongation) with macrolide antibiotics, in particular with erythromycin and clarithromycin
erythromycin should not be given to patients with:
a history of QT interval prolongation (congenital or documented acquired QT interval prolongation) or ventricular cardiac arrhythmia, including torsades de pointes
electrolyte disturbances (hypokalaemia or hypomagnesaemia due to the risk of arrhythmia associated with QT interval prolongation)
consider the potential benefit of treatment against the cardiac risks when prescribing in patients at increased risk of a cardiac event; patients in whom caution is needed are those with:
cardiac disease or heart failure
fluoroquinolones are authorised for use in serious, life-threatening bacterial infections
systemic (by mouth or injection) and inhaled fluoroquinolones have been associated with a small increased risk of heart valve regurgitation, with one retrospective case-control study suggesting a 2-fold increased relative risk with current oral fluroquinolone use compared with the risk with use of amoxicillin or azithromycin
fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in the following patients at risk:
patients with congenital heart valve disease or pre-existing heart valve disease
patients diagnosed with connective tissue disorders (for example, Marfan syndrome or Ehlers-Danlos syndrome)