Warnings NephroTOX 2024

South Africa Warning _ Proton Pump Inhibitors (PPIs) : Risk of acute tubulointerstitial nephritis (TIN)

The South African Health Products Regulatory Authority (SAHPRA) has alerted health-care professionals on the risk of acute tubulointerstitial nephritis (TIN) associated with use of Proton Pump Inhibitors (PPIs: pantoprazole, dexlansoprazole, esomeprazole, and rabeprazole). TIN (previously called interstitial nephritis) is characterized by an inflammatory reaction within the tubulointerstitial space of the kidney, and acute TIN can result in acute kidney injury. Symptoms and signs of acute TIN may be nonspecific and are often absent unless symptoms and signs of renal failure develop. Many patients develop polyuria (increased frequency of urination) and nocturia (the need for patients to get up at night on a regular basis to urinate).

Health-care professionals are advised that treatment by PPIs must be stopped when TIN is suspected; PPIs are contraindicated in patients who previously experienced TIN while on treatment with PPIs; and patients should be asked to report any alteration in urine volumes or if they suspect that there is blood in their urine while on PPIs.

Reference: Safety Information and Updates, SAHPRA, 30 October 2023 (link to the source within www.sahpra.org.za)

WHO Pharmaceuticals Newsletter No. 2, 2024. p9 ; Geneva: World Health Organization; 2024.


Canada Informing _ Dimethyl fumarate : Potential risk of Fanconi syndrome not supported

Health Canada’s review did not find sufficient evidence to support a potential risk of Fanconi syndrome (a syndrome of inadequate reabsorption in the proximal renal tubules of the kidney) with use of dimethyl fumarate.

Dimethyl fumarate is indicated for the treatment of adult patients with a form of multiple sclerosis.

Health Canada reviewed the available information from searches of the Canada Vigilance database, international databases, and scientific literature. As a result, sufficient evidence to support a link between the risk of Fanconi syndrome and the use of dimethyl fumarate for the treatment of multiple sclerosis was not found.

The safety review was triggered by a labelling update for dimethyl fumarate-containing products by the EMA. Fanconi syndrome was reported in Europe for a product containing dimethyl fumarate in combination with other fumaric acid esters used to treat psoriasis. On the other hand, in Canada, dimethyl fumarate is not authorized for the treatment of psoriasis. In addition, only single ingredient dimethyl fumarate, and not fumaric acid ester compounds, is authorized in Canada.

Reference: Health Product InfoWatch, Health Canada, November 2023 (link to the source within www.hc-sc.gc.ca)

WHO Pharmaceuticals Newsletter No. 2, 2024. p9 ; Geneva: World Health Organization; 2024.


France Warning _ Ketamine : Risk of prolonged use leads to severe liver and uro-nephrological damage

The ANSM is reminding health-care professionals by issuing a Direct Health-care Professional Communication (DHPC) that there is an increase in the number of hepatobiliary (cholestasis or cholangitis) and uro-nephrological (non-infectious cystitis, interstitial cystitis, acute renal failure, hydronephrosis), most often serious, after prolonged or repeated use of ketamine. Ketamine is a narcotic whose prescription is limited to 28 days.

The ANSM reminded health-care professional to respect the recommended dosages of ketamine and to limit exposure over time, and monitor liver function, renal function and urinary cytology closely if taken repeatedly or over prolonged time.

Reference: Security information, ANSM, 30 August 2023 (link to the source within ansm.sante.fr)

WHO Pharmaceuticals Newsletter No. 1, 2024. p10 ; Geneva: World Health Organization; 2024.

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