MHRA Updates Quarter 1 2019
Updates from the MHRA for the first quarter of 2019
Drug Safety Update includes:
- Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines
- Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
- Yellow Card App: download the updated App to receive the latest MHRA safety news and report suspected side effects, including in pregnancy
- Carbimazole: increased risk of congenital malformations; strengthened advice on contraception
- Carbimazole: risk of acute pancreatitis
- SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)
- Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects
- Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic events
- Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed?
Letters sent to healthcare professionals:
- Discontinuation of Zovirax (Aciclovir) eye ointment
- Recall of irbesartan/hydrochlorothiazide products
- Lartruvo▼ (olaratumab): no new patients to be prescribed due to study showing no clinical benefit
- Supply of Standard Export pack of Quadrivalent Influenza Vaccine (split virion, inactivated) suspension for injection in a prefilled syringe PL 46602/0017 - Lot R3J824V, Expiry 31/08/2019 – Single Packs
- Vyxeos (cytarabine, daunorubicin): temporary interruption of UK packaging; provide English-language patient information leaflets with imported Nordic batches
- OZURDEX 700 micrograms intravitreal implant (dexamethasone): Update on silicone particle issue: Supply of new (defect-free) stock and recall of remaining stock in the market
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Published 17/04/19. Medicines Update blogs are correct at the time of publication.
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