Tag Archives: MHRA

Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic administration

Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal, epidural, intra-articular, topical dermal, and periocular routes.

Advice for healthcare professionals:

  • advise patients to report any blurred vision or other visual disturbances during corticosteroid treatment
  • consider referral to an ophthalmologist for evaluation of possible causes if a patient presents with vision problems
  • report suspected adverse reactions to us on a Yellow Card

Please see the MHRA Drug Safety Update website for more information.

Drug Safety Update volume 11 issue 1, August 2017: 2.

Link

MHRA Drug Safety Update June 2017

A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (vol 10, issue 11, June 2017) has been published and includes articles on:

  • Denosumab (Prolia, Xgeva▼): reports of osteonecrosis of the external auditory canal
  • Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged skin
  • Pseudoephedrine and ephedrine: regular review of minimising risk of misuse in the UK
  • e-cigarettes and refill containers (e-liquids): report suspected side effects and safety concerns
  • Letters sent to healthcare professionals in May 2017
  • Medical Device Alerts issued in May 2017
Link

MHRA Drug Safety Update May 2017

A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (vol 10, issue 10, May 2017) has been published and includes articles on:

  • Finasteride: rare reports of depression and suicidal thoughts;
  • New e-learning modules on reporting suspected adverse drug reactions; and
  • Letters sent to healthcare professionals in April 2017, including reminder of retigabine (Trobalt) withdrawal.

MHRA safety alert -Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use

When prescribing selective serotonin reuptake inhibitors (SSRIs), prescribers are reminded to enquire about cocaine use when considering drug–drug interactions and the need to avoid concurrent use of multiple serotonergic drugs. They should also note the potential increased risk of bleeding when citalopram is prescribed to patients taking cocaine.

Possible interactions with illicit drugs should be considered when prescribing any medicines that have the potential to interact adversely.

New toolkit supports better understanding of the risks of valproate and pregnancy

The Medicines and Healthcare products Regulatory Agency (MHRA) today welcomed the launch of a new toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.

Valproate (Epilim, Depakote and other generic brands) is a treatment for epilepsy and bipolar disorder and is prescribed to thousands of women. It is associated with a risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

MHRA strengthened warnings on the risks of valproate in pregnancy last year, as understanding of the extent of these risks had increased. Up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects, if valproate is taken during pregnancy. The new toolkit addresses concerns that the risks of valproate are not being adequately explained to female patients.

Developed in consultation with stakeholders including healthcare professional and patient groups, the toolkit includes a credit card sized patient card to be issued by pharmacists, booklets for healthcare professionals and for patients together with a checklist of important questions and discussion points to be kept with the patient’s file. Warnings will appear on the medicine’s packaging later this year.

The MHRA is asking GPs, pharmacists, neurologists, psychiatrists, and other relevant healthcare and mental health professionals to use the toolkit to help facilitate discussion of the risks with their patients.

More information is available at https://www.gov.uk/government/news/new-toolkit-supports-better-understanding-of-the-risks-of-valproate-and-pregnancy