The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2019 (PDF).
This issue warns that yellow fever vaccine (Stamaril®) must not be given to anyone who is immunosuppressed and extreme caution needs to be used people aged 60 years and older due an increased risk of life-threatening reactions. This follows two recent reports of fatal adverse reactions with suspected yellow fever vaccine-associated viscerotropic disease (YEL-AVD) shortly after administration of the vaccine.
This issue also advises that the Annual Risk Acknowledgement Form, which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines, has been updated. The updated form dated March 2019 should be used in future reviews.
Readers are reminded that pregabalin (Lyrica®) and gabapentin (Neurontin®) were rescheduled as controlled drugs with effect from the start of this month. It is recommended that healthcare professionals evaluate patients carefully for a history of drug abuse before prescribing pregabalin and gabapentin and observe patients for development of signs of abuse and dependence.
Finally this month, the summary of letters to healthcare professionals includes a letter advising of the new restrictions and precautions for use of fluoroquinolone antibiotics as covered in Drug Safety Update last month.
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 March 2019 (PDF).
This issue advises clinicians of new restrictions and precautions for use of fluoroquinolone antibiotics. This is due to due to very rare reports of disabling and potentially long-lasting or irreversible side effects. Following an EU wide review it is now recommended that these antibiotics are not used for mild to moderate infections unless other antibiotics that are commonly recommended for these infections are considered inappropriate.
This issue also contains new guidance on effective contraception and pregnancy testing during use of teratogenic medication. This guidance notes that effective or highly effective contraceptives methods are defined by the typical failure rate in the first year with highly effective methods defined as a failure rate of less than 1%. This includes male and female sterilisation and long-acting reversible contraceptive (LARC) methods. A table is linked in this section that is useful in determining if pregnancy testing should be performed and categorises the efficacy of different methods of contraception.
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 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.
