ADR that result in revision of patient information
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| The United Kingdom: SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that post-marketing cases of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) have been associated with the use of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Medicines in the UK are those containing dapagliflozin, canagliflozin, empagliflozin, and ertugliflozin.
An EU review has assessed reported cases of Fournier’s gangrene across the class of SGLT2 inhibitors. Although diabetes mellitus is a risk factor for the development of Fournier’s gangrene, some of the EU post-marketing reports were considered possibly to be related to the use of SGLT2 inhibitors. Fournier’s gangrene usually occurs almost exclusively in men. However, around a third of the EU cases reviewed were reported in women. MHRA is also aware of rare occurrences of Fournier’s gangrene in patients on SGLT2 inhibitors in the USA. MHRA has received 6 Yellow Card reports (4 in men and 2 in women) of UK cases of Fournier’s gangrene in association with SGLT2 inhibitors up to Jan 2019. This corresponds to a UK estimated exposure to SGLT2 inhibitors of 548,565 patient-years of treatment.
Warnings about Fournier’s gangrene will be added to the product information for all SGLT2 inhibitors. A letter has also been sent to advise healthcare professionals of the risk.
Healthcare professionals are advised:
- Post-marketing cases of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) have been associated with the use of SGLT2 inhibitors.
- Fournier’s gangrene is a rare but serious and potentially life-threatening infection.
- If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and urgently start treatment (including antibiotics and surgical debridement as required).
- Urogenital infection or perineal abscess may precede necrotising fasciitis.
- Advise patients to seek urgent medical attention if they experience severe pain, tenderness, erythema, or swelling in the genital or perineal area, accompanied by fever or malaise.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/sglt2-inhibitors-reports-of-fournier-s-gangrene-necrotising-fasciitis-of-the-genitalia-or-perineum
In Hong Kong, there are 17 registered pharmaceutical products containing SGLT2 inhibitors, including canagliflozin (2 products), dapagliflozin (5 products) and empagliflozin (10 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to canagliflozin, 5 cases related to dapagliflozin and 1 case related to empagliflozin, but these cases are not related to Fournier’s gangrene. Related news was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 30 Aug 2018. Letters to inform local healthcare professionals of the risk of Fournier’s gangrene were issued on the same day. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Feb 19, 2019
Issued at HKT 17:00
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