Antimicrobial Drug Safety Updates

Drug safety update information is located on the MHRA website and may be viewed directly via the following link: www.gov.uk/drug-safety-update

A selection of antimicrobial drug related alerts that have been noted at the Antimicobial Stewardship Group are listed below:

• Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions

  Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.

  Therapeutic area: Infectious disease and 1 others
  Published: 26 April 2023
• Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions

  Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…

  Therapeutic area: Dermatology and 3 others
  Published: 15 February 2022
• Chloramphenicol eye drops containing borax or boric acid buffers: use in children younger than 2 years

  Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, we have concluded that the balance between the benefits and risks of chloramphenicol eye drop…

  Therapeutic area: Infectious disease 
  Published: 7 July 2021
• Aminoglycosides (gentamicin, amikacin, tobramycin, and neomycin): increased risk of deafness in patients with mitochondrial mutations
  Evidence suggests an increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations, including cases in which the patient’s aminoglycoside serum levels were within the recommended range. The…
  
  Therapeutic area: Infectious disease
  Published: 7 January 2021
• Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk

  Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence).

  Therapeutic area: Infectious disease
  Published: 17 December 2020
• Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban

  Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Erythromycin should not be given to patients with a history of QT interval prolongation…

  Therapeutic area: Haematology and 1 others
  Published: 17 December 2020
• Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis

  Updates have been made to the magnitude of the known risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy as a result of new epidemiological data. The risk is particularly increased i…

  Therapeutic area: Infectious disease and 1 others
  Published: 17 December 2020.