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February 2019 Drug Safety Update published

Carbimazole notices

February 20th 2019

Tagged: MHRA alert

By MHRA

The February 2019 Drug Safety Update is now online. Articles include:

Carbimazole:
increased risk of congenital malformations; strengthened advice on contraception:
Strengthened advice has been added to the product information due to a review of an increased risk of congenital malformations. There are no requirements for a pregnancy prevention programme, but warnings added to the leaflet advise women who are pregnant or are planning a pregnancy to seek immediate advice from their prescriber.

risk of acute pancreatitis Previous episodes of acute pancreatitis during treatment with carbimazole is now a contraindication due to a risk of reoccurrence with a decreased time to onset.

SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)

Letters and drug alerts sent to healthcare professionals in January 2019:

  • Lartruvo (olaratumab) – no new patients to be initiated after study shows no clinical benefit
  • Quadrivalent influenza vaccine (split virion, inactivated) – Supply of standard export pack
  • Class 2 medicines recalls batches of for irbesartan/hydrochlorothiazide and irbesartan tablets.

Medical Device Alerts issued in January 2019 – including information about skin hypersensitivity reactions with FreeStyle Libre flash glucose sensor and advice that patients should not be using creams, patches, or sprays under the device due to possible effect on device performance.

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