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.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Rivaroxaban (Xarelto®) has been accepted for restricted use when co-administered with acetylsalicylic acid for the prevention of atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral artery disease who are at high risk of ischaemic events. The restriction limits use to patients with stable coronary artery disease that does not require dual antiplatelet therapy.
Eslicarbazepine (Zebinix®) has been accepted for restricted use as adjunctive therapy in adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation. The restriction limits use to patients with highly refractory epilepsy who have been heavily pre-treated and remain uncontrolled with existing anti-epileptic drugs.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2019 (PDF).
This issue advises clinicians that tapentadol (Palexia®) may increase seizure risk in patients taking other medicines that lower seizure threshold. It is recommended to use with care in patients with a history of seizure disorders or epilepsy. Serotonin syndrome has also been reported when tapentadol is used in combination with serotoninergic antidepressants.
Readers are also advised that the Yellow Card App has been updated to make it easier to use and new features have been added, such as the ability to receive updates via the app.
Finally this month, the summary of letters to healthcare professionals includes notification that aciclovir eye ointment (Zovirax®) is being discontinued globally due to challenges in guaranteeing a sustainable product supply. It is expected current supplies will last until around June 2019. There is no generic direct alternative but ganciclovir has been recommended as an appropriate first-line alternative.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2018 (PDF).
This issue notes that oral lidocaine-containing products for infant teething are now only to be available under the supervision of a pharmacist. This is to ensure that appropriate guidance about managing infant teething symptoms can be given and lidocaine-containing products only be used when simple measures have failed to provide sufficient relief.
This issue also reports that compliance with the new valproate measures for pregnancy prevention currently appears to be variable by CCG. All healthcare professionals must continue to identify and review all female patients on valproate and provide them with the patient information materials every time they attend their appointments or receive their medicines.
Readers are also advised the packaging and patient information leaflets for emollients will soon be updated warning about the risk of severe and fatal burns. These warnings are being are being extended to all paraffin-based emollients regardless of paraffin concentration and also for paraffin-free emollients where there is still a risk.
This issue also notes that direct-acting antivirals for chronic hepatitis C have been associated with an increased risk of hypoglycaemia in patients with diabetes. It is suggested the glucose levels are monitored more closely, particularly in the first 3 months of treatment, with diabetic treatment adjusted accordingly.
Also, this issue advises that hydrocortisone muco-adhesive buccal tablets should not be used off-label for adrenal insufficiency in children. This is due to serious risks of insufficient cortisol absorption and life-threatening adrenal crisis. Licensed hydrocortisone products for adrenal replacement therapy are available and should be used.
Finally this month, the summary of letters to healthcare professionals includes a letter circulated about the risk of aortic aneurysm and dissection, particularly on older patients, using fluoroquinolones and notification that Quadrivalent Influenza Vaccine (under the brand name VaxigripTetra®▼) intended for export to Europe has been authorised for use in the UK to satisfy higher than expected demand.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Brivaracetam (Briviact®) has been accepted for restricted use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in children from 4 years to ≤15 years of age with epilepsy. The restrictions limits use to patients with refractory epilepsy and treatment should be initiated by physicians who have appropriate experience in the treatment of epilepsy.
Ciclosporin eye drops (Verkazia®) have been accepted for use in the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents (until the age of 18)
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
