Studies have shown that many patients do not have regular monitoring of renal function whilst taking 5-ASA (from Heap et al 2016). In 1990, the UK Committee on the Safety of Medicines issued an alert on nephrotoxic reactions to mesalazine, and in 2001, the Drug and Therapeutics bulletin suggested that annual checking of renal function in patients taking 5-ASA was of unproven value but 'seems prudent'.

The BNF didn't contain advice about monitoring renal function in patients taking 5-ASA until 2004, and that advice only referred to elderly patients. Recommendations regarding monitoring of renal function on 5-ASA drugs have changed over the years, and also haven't necessarily been consistent across different sources of guidance. In addition, these publications also probably don't reflect the knowledge of the majority of GPs in particular regarding the potential need to monitor renal function.

The latest BSG guidelines on management of inflammatory bowel disease in adults make a strong recommendation that renal function is checked before treatment with 5-ASA, after two to three months of treatment, and annually thereafter - with more close monitoring if renal function is impaired.

The current BNF recommends that renal function should be monitored before starting an oral aminosalicylate, at three months of treatment, and then annually during treatment, with more frequent monitoring in patients with renal impairment.

Issues identified from MDU cases

The claims notified to the MDU tend to concern patients who either require renal replacement therapy or those with very significant renal impairment who may well reach end stage renal disease in the future. Therefore in those claims that have been settled, compensation payments have been in the region of £500,000.

Some of the issues common to those cases seen by the MDU include:

failure by secondary care doctors recommending treatment with 5-ASA drugs to advise the GPs about recommendations to monitor renal functions
failure by both primary and secondary care to check renal function before starting treatment with 5-ASA drugs
failure by both primary and secondary care to monitor renal function during 5-ASA treatment
a lack of regular medication reviews by general practitioners in patients receiving long term treatment with 5-ASA drugs
a failure to act on abnormal renal function resulting in a delay in diagnosis of 5-ASA associated renal impairment in both primary and secondary care.

Risk management of mesalazine induced renal failure

Learn and develop with the MDU

Dr Claire Wratten

Risk management of mesalazine induced renal failure