MHRA Highlights Cutaneous Amyloidosis Risk With Insulins

Pavankumar Kamat

September 29, 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update highlighting the risk of cutaneous amyloidosis at the injection site in patients receiving insulin injections.

Insulin preparations can result in amyloid deposition under the skin at the injection site, particularly if the same sites are repeatedly used instead of rotating the sites. This could subsequently hamper insulin absorption and affect glycaemic control. A recent European review found a causal relationship between cutaneous amyloidosis and all insulins and insulin-containing products.

The European review could not determine the frequency of cutaneous amyloidosis from the data available, but reported cases have been very rare. It is likely that several cases of cutaneous amyloidosis may be under-reported and misdiagnosed as lipohypertrophy.

As of end of July 2019, there were two reports of cutaneous amyloidosis in patients receiving insulin therapy in the UK, received through the Yellow Card Scheme.

It is important that clinicians remind patients to rotate injection sites within the same body region and monitor blood glucose after a change in the injection site. Additionally, clinicians should also consider cutaneous amyloidosis as a differential diagnosis to lipodystrophy when there is a presentation of subcutaneous lumps at the injection site.

The Summaries of Product Characteristics and Patient Information Leaflets are being updated to reflect the risk of cutaneous amyloidosis.

This article originally appeared on Univadis, part of the Medscape Professional Network.

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