BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

July 25 2018 Switching to sulfonylureas in type 2 diabetes has been linked with an increased risk...

Effect of omega-3 or other fatty acids on heart disease is negligible finds Cochrane review

Effect of omega-3 or other fatty acids on heart disease is negligible finds Cochrane review

July 19 2018 Cochrane researchers have published research indicating that omega 3 supplements...

DOACs associated with reduced risk of major bleeding compared to warfarin

DOACs associated with reduced risk of major bleeding compared to warfarin

July 11 2018 Direct oral anticoagulants (DOACs) have been associated with reduced risks of major...

Recorded penicillin allergy associated with increased risk of MRSA and C difficile

Recorded penicillin allergy associated with increased risk of MRSA and C difficile

July 3 2018 People who have a record of penicillin allergy are at an increased risk of developing...

MPS advises of need for better awareness of cauda equina red flag symptoms

MPS advises of need for better awareness of cauda equina red flag symptoms

May 9 2018 The Medical Protection Society is advising doctors of a revision to the NICE Clinical...

  • BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

    BMJ: ‘Adding a sulfonylurea to metformin looks safer than switching to one’

    Wednesday, 25 July 2018 14:07
  • Effect of omega-3 or other fatty acids on heart disease is negligible finds Cochrane review

    Effect of omega-3 or other fatty acids on heart disease is negligible finds Cochrane review

    Thursday, 19 July 2018 10:36
  • DOACs associated with reduced risk of major bleeding compared to warfarin

    DOACs associated with reduced risk of major bleeding compared to warfarin

    Wednesday, 11 July 2018 13:22
  • Recorded penicillin allergy associated with increased risk of MRSA and C difficile

    Recorded penicillin allergy associated with increased risk of MRSA and C difficile

    Tuesday, 03 July 2018 16:51
  • MPS advises of need for better awareness of cauda equina red flag symptoms

    MPS advises of need for better awareness of cauda equina red flag symptoms

    Wednesday, 09 May 2018 16:01

a pharmacist woman consultationFebruary 13 2018

Doctors should not initiate Esyma (ulipristal acetate) in women with uterine fibroids for the time being, the European Medicines Agency has advised.

Its Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation, said the EMA. “No new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.”

In addition, women taking Esmya for uterine fibroid should have regular liver monitoring. “All women taking Esmya should have a liver function test at least once a month during treatment. If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient. Liver tests should be repeated 2 to 4 weeks after stopping treatment.

“For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately. If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.”

The MHRA has also issued a ‘Dear Doctor’ letter via the Central Alerting System advising of the PRAC recommendations. It points out: “The emergency contraceptive ellaOne also contains ulipristal acetate (single-dose, 30mg). No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.”

The PRAC’s final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion.

Links:  
EMA announcement    
MHRA CSA announcement       

Clinical News

July 27 2018 Adolescent boys will be offered the human papilloma virus (HPV) vaccine to protect them from cancer, the Department of Health and Social Care has announced.
July 20 2018 Doctors are being reminded to ensure that any patient or other records which may be relevant to the UK Infected Blood Inquiry are not destroyed. Earlier this month, the Inquiry’s Chair, Sir...