World Health Organization has claimed dexamethasone acts as effective medicine for Covid-19 patients.WHO is in the process of updating treatment guidelines to include dexamethasone or other steroids
Dexamethasone is a corticosteroid used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects.
It was tested in hospitalized patients with COVID-19 in the United Kingdom’s national clinical trial RECOVERY and was found to have benefits for critically ill patients.
According to preliminary findings shared with WHO (and now available as a preprint), for patients on ventilators, the treatment was shown to reduce mortality by about one third, and for patients requiring only oxygen, mortality was cut by about one fifth.
Yes, dexamethasone has been on the WHO Model List of Essential Medicines (EML) since 1977 for several indications in multiple formulations. Since 2013, dexamethasone (Injectable formulation) has been indicated for respiratory distress syndrome in new-borns. Prednisolone is also on the EML and was included in 1984.
Dexamethasone and prednisolone are included on the EML for the following indications:
- allergic or hypersensitivity conditions, without further specifying the type
- pain and oedema due to malignancy in palliative care
- nausea and vomiting,
- as part of treatment protocols for some blood tissue cancers.
These indications are broad and can also include cytokine-related lung injury and as prevention or treatment of acute respiratory distress syndrome (ARDS) associated with severe acute respiratory infections (i.e. viral pneumonia). Both medicines are also recommended in children.
Dexamethasone was used in the Recovery Trial in oral (liquid or tablets) or intravenous preparation 6 mg once daily for ten days.
In pregnancy or breastfeeding women, prednisolone 40 mg administered by mouth (or intravenous hydrocortisone 80 mg twice daily) should be used instead of dexamethasone.
- Note: It is permitted to switch between the two routes of administration according to clinical circumstances.
What are the typical side effects of dexamethasone?
Dexamethasone is generally safe. It presents a favourable benefit-risk profile, particularly in patients with severe forms of pneumonia, while the benefit is less prominent in patients with non-severe pneumonia. As the treatment is short, even at high doses, corticosteroids are not associated with serious side effects. Potentially higher blood glucose levels (hyperglycaemia) are temporary.
Prolonged use (I.e., used for more than two weeks) may be associated with adverse events such as glaucoma, cataract, fluid retention, hypertension, psychological effects (e.g., mood swings, memory issues, confusion or irritation), weight gain, or increased risk of infections and osteoporosis.
To reiterate: All these adverse events are not associated with short term use (with the exception of hyperglycaemia that can worsen diabetes).Does WHO recommend the use of dexamethasone for COVID-19 patients?
WHO is in the process of updating treatment guidelines to include dexamethasone or other steroids.Can steroids be used in the elderly/children/pregnancy?
They can be used in children and the elderly. In pregnancy, the Recovery trial used prednisolone orally or hydrocortisone by intravenous infusion instead of dexamethasone. Steroids are ubiquitous in terms of geographic use.
Dexamethasone is off-patent and has been marketed in different formulations (e.g., tablets, liquid, solution for injection) for many years. It is generally available in most countries. There are several manufacturers of the product. One manufacturer has already been prequalified by WHO (Kern Pharma in Spain) while another is under assessment.
The most common formulations are:
- Tablets: 0.5mg, 0.75mg, 1mg, 1.5mg, 2mg, 4mg and 6mg
- Oral Solution: 0.5mg/5ml, 20mg/5ml and 1mg/ml (concentrate)
- Injectable suspension: 4mg/ml, 20mg/5ml
In recent years there have been occasional reports of shortages of this product. It is important to quickly understand the projected volumes for COVID-19 utilization and manufacturing capacity to help assess the impact for existing indications and the potential need for substitute therapies, to ensure all patients retain access to a safe, effective, quality, affordable product to meet their therapeutic needs.
There are likely no restrictions, as dexamethasone is authorized worldwide.