Drug Safety Update - February 2019
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2019 (PDF).
This issue advises clinicians of the increased risk of congenital malformations when carbimazole is used during pregnancy, especially when administered in the first trimester of pregnancy and at high doses. Women of childbearing potential should use effective contraception during treatment with carbimazole and it must only be used during pregnancy when clinically indicated and after a strict individual benefit/risk assessment.
Readers are also advised that carbimazole treatment must be immediately and permanently stopped if acute pancreatitis occurs. Re-exposure to carbimazole may result in life-threatening acute pancreatitis with a decreased time to onset.
Clinicians are also notified of an association between Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) and the use of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Fournier’s gangrene is a rare but potentially life-threatening infection that requires urgent medical attention. If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently.
Finally this month, the summary of letters to healthcare professionals includes a warning that application of creams, patches or sprays under the FreeStyle Libre flash glucose sensor in order to reduce skin reactions may affect device performance. The letter recommends consideration of the suitability of continued use of this device for patients with skin reactions.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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