MHRA Drug Safety Update (February 2022): Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions

• An observational study has shown that co-administration of azithromycin with hydroxychloroquine in patients with rheumatoid arthritis is associated with an increased risk of cardiovascular events (including angina or chest pain and heart failure) and cardiovascular mortality
• 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
• See the safety update for advice to give to patients

Azithromycin

• Tablets 250mg (£1.13 = 4 tablets), 500mg (£1.08 = 3 tablets)
• Oral suspension 200mg/5ml (£4.06 = 15ml)

Indications

• Chlamydia trachomatis - (second line)
  • Chlamydia trachomatis - (pregnancy) (unlicensed indication) (first line)
• Lyme disease - (unlicensed indication) (second line)
• Chronic Pelvic Pain Syndrome
• Gonorrhoea - (specialist input)

Clarithromycin

• Tablets 250mg, 500mg (£2.62, £5.87 = 14 tablets)
• Oral suspension 125mg/5ml, 250mg/5ml (£3.54, £4.90 = 70ml)
• Powder for solution for intravenous infusion vial 500mg

Indications

• Acute sore throat
• Acute otitis media
• Acute sinusitis
• Acute cough, bronchitis
• Acute exacerbation of COPD - (first line)
• Community acquired pneumonia
• Non-cystic fibrosis bronchiectasis (acute exacerbation)
• Eradication of H. pylori
• Impetigo
• Infected eczema (penicillin allergy)
• Cellulitis
• Leg ulcer
• Dental abscess

Erythromycin

• Gastro-resistant tablets 250mg (£1.96 = 28 tablets)
• Powder for solution for infusion vial 1g

Indications

• Moderate to severe acne:
  • Adults/ children and young people over 12 years - plus Epiduo OR Azelaic acid
• Acute sore throat - (pregnancy)
• Acute otitis media - (pregnancy)
• Acute sinusitis - (pregnancy)
• Acute cough, bronchitis
• Community acquired pneumonia
• Chlamydia trachomatis - (first line) (pregnancy)
• Impetigo - (pregnancy)
• Infected eczema (penicillin allergy in pregnancy)

Notes:

1. MHRA Drug Safety Update (December 2020): Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis
   1. an increased risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy has been reflected in the product information for some time
   2. 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
   3. consider the benefit of erythromycin therapy against the potential risk of developing infantile hypertrophic pyloric stenosis
   4. advise parents to seek advice from their doctor if vomiting or irritability with feeding occurs in infants during treatment with erythromycin

Pristinamycin

• Tablets 500mg (unlicensed preparation)