Macrolides with hydroxychloroquine or chloroquine. MHRA drug safety update

Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions

MHRA Drug Safety Update February 2022

Advice for healthcare professionals:

• 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
• If there is a clinical need to prescribe systemic macrolide antibiotics with hydroxychloroquine or chloroquine, use caution in patients with risk factors for cardiac events and follow advice in the product information for each medicine
• Be vigilant for psychiatric reactions associated with hydroxychloroquine or chloroquine, especially in the first month of treatment; events have been reported in patients with no prior history of psychiatric disorders
• Report suspected adverse drug reactions on a Yellow Card

Advice for healthcare professionals to give to patients and carers:

• Some antibiotics (known as macrolides) taken by mouth or given as an injection at the same time as hydroxychloroquine or chloroquine have been associated with an increased risk of side effects that affect the heart
• Seek urgent medical help if you have any signs of problems with your heart (for example, palpitations, fainting, chest pain, or unexplained breathlessness)
• Some patients have also reported mental health symptoms when they started treatment with hydroxychloroquine or chloroquine
• Speak to your doctor as soon as possible if you or your family members or caregivers notice any new or worsening mental health symptoms
• Read the patient information leaflet that comes with your medicine (hydroxychloroquine or chloroquine) and keep it handy in case you need to read it again