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...

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...

Syphilis and gonorrhoea diagnoses see significant increase

Syphilis and gonorrhoea diagnoses see significant increase

June 11 2018 Annual reporting of sexually transmitted infection diagnoses has increased 0.3% in...

Anticholinergics linked to increased risk of dementia

Anticholinergics linked to increased risk of dementia

April 30 2018 Anticholinergic drugs used in helping control some involuntary muscle movement...

  • 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 13:55
  • 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 13:11
  • 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 16:42
  • Syphilis and gonorrhoea diagnoses see significant increase

    Syphilis and gonorrhoea diagnoses see significant increase

    Monday, 11 June 2018 14:16
  • Anticholinergics linked to increased risk of dementia

    Anticholinergics linked to increased risk of dementia

    Monday, 30 April 2018 12:08

Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
More inWhite Papers  

EMA

January 13 2016

European medicines regulators approved 93 medicines for marketing authorisations in 2015, including 39 new active substances. A third of new active substances were for the treatment of cancer, the European Medicines Agency said in its overview of human medicines activity last year.

Therapeutic innovations were seen in particular for the treatment of certain cancers, cardiovascular diseases, and in the areas of haematology and neurology.

New therapeutic innovations highlighted in the report are:

table

The EMA also approved 54 indication extensions, and has flagged up the following as being particularly noteworthy:

  • Humira for patients with acne inversa
  • Imbruvica for patients with Waldenstrӧm’s macroglobulinaemia
  • Perjeta for patients with breast cancer undergoing surgery
  • Tafinlar and Mekinist a combination treatment for patients with advanced melanoma
  • Xalkori for previously untreated patients with non-small cell lung cancer with ALK mutation.

EMA has also approved 18 orphan medicines - drugs developed with European Union support to help treat patients with rare diseases:

  • Blincyto for patients with acute lymphoblastic leukaemia
  • Farydak for patients with multiple myeloma
  • Hetlioz for blind adults with sleep-wake disorder
  • Kanuma for patients with lysosomal acid lipase deficiency
  • Kyprolis for patients with multiple myeloma
  • Lenvima for patients with thyroid cancer
  • Strensiq for patients with childhood hypophosphatasia
  • Unituxin for patients with brain cancer (neuroblastoma)

Other activity conducted in 2015 included accelerated assessments for five medicines, and condition marketing authorisations for three products for cancer indications. It also “adopted a positive scientific opinion for Mosquirix, the first vaccine for malaria to be assessed by a regulatory authority worldwide.”

Among the safety advice issued in 2015 were:

  • new recommendations for bisphosphonates and denosumab included in product information and the introduction of a patient reminder card to minimise risk of jaw osteonecrosis
  • recommendations included in product information to avoid the risk of slow heart rate when Harvoni, Sovaldi and Daklinza are used with the antiarrhythmic drug amiodarone
  • the introduction of an adrenaline auto-injector training device and audio-visual training materials
  • a warning to restrict the use of mycophenolate in pregnancy.

“EMA reviewed the product information of all HIV medicines and for most of them decided to remove certain warnings in relation to the impact on body fat changes and lactic acidosis, in light of new data available. These changes allow patients and healthcare professionals to use and prescribe these medicines in the best possible way,” it added.

Having reviewed data surrounding reports of two syndromes and a possible link to the human papilloma virus vaccine (HPV), it concluded the available evidence does not support a causal link with complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women.

Links:

EMA announcement

EMA ‘Human Medicines Highlights 2015’

Clinical News

July 31 2018 General practices employing pharmacists are citing improved capacity to see patients and workload changes as the main benefits of the scheme.
July 25 2018 Switching to sulfonylureas in type 2 diabetes has been linked with an increased risk of complications compared with staying on metformin, a BMJ study has concluded. However, the study has...