Response to ‘Hydrocortisone suspension formulations are not necessarily the same in the treatment of children with congenital adrenal hyperplasia’

Extract

We were delighted to see the letter to the editor by Sarafoglou et al. (1). The authors highlight important points made in our recent paper on paediatric population pharmacokinetic modelling to assess hydrocortisone replacement dosing regimens in young congenital adrenal hyperplasia (CAH) patients (2).

We acknowledge that extemporaneously compounded hydrocortisone suspensions from specific pharmacies can provide adequate replacement therapy as referenced by Sarafoglou et al. (3, 4). However, as discussed by Sarafoglou, extemporaneously compounded drugs are not subject to the same quality control measures as commercial medications licensed by the US Food and Drug Administration (FDA), which can lead to inconsistent quality between different compounding pharmacies or between batches, and varied results in patients with some patients becoming Cushingoid and some adrenally insufficient (5). In the United States of America (US), there has been little innovation in hydrocortisone therapies for the treatment of CAH over the last 60 years and, currently, there is still no licenced paediatric-specific preparation of hydrocortisone in the US. We acknowledge that in our, Europe-focussed study, this was not referenced.