Lancet study rates 21 antidepressants for acute use in major depressive disorder

Lancet study rates 21 antidepressants for acute use in major depressive disorder

February 23 2018 A meta-analysis of data on 21 antidepressants has concluded that all are more...

EMA says no new patients should be started on Esyma for uterine fibroids

EMA says no new patients should be started on Esyma for uterine fibroids

February 13 2018 Doctors should not initiate Esyma (ulipristal acetate) in women with uterine...

New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

February 13 2018 The European Medicines Agency has issued new recommendations regarding use of...

EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

February 12 2018 The European Medicines Agency has updated advice regarding the use of retinoids...

New Drug Safety Update issued on need for contraception with mycophenolate mofetil

New Drug Safety Update issued on need for contraception with mycophenolate mofetil

February 9 2018 The medicines regulator has issued a Drug Safety Update relating to mycophenolate...

  • Lancet study rates 21 antidepressants for acute use in major depressive disorder

    Lancet study rates 21 antidepressants for acute use in major depressive disorder

    Friday, 23 February 2018 10:03
  • EMA says no new patients should be started on Esyma for uterine fibroids

    EMA says no new patients should be started on Esyma for uterine fibroids

    Tuesday, 13 February 2018 12:18
  • New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    New warnings issued for pregnancy and women using valproate for epilepsy, migraine, or bipolar

    Tuesday, 13 February 2018 12:11
  • EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    EMA updates recommendations on avoidance of retinoids in pregnancy and effect on mental health

    Monday, 12 February 2018 14:21
  • New Drug Safety Update issued on need for contraception with mycophenolate mofetil

    New Drug Safety Update issued on need for contraception with mycophenolate mofetil

    Friday, 09 February 2018 15:01

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
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inhalerMarch 23 2016

While inhaled corticosteroids are known to increase the risk of pneumonia in chronic obstructive pulmonary disease, the benefits outweigh the risks, a review has concluded.

Conducted by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), the review also looked at whether there were any differences in the risk of pneumonia between products. It “did not find conclusive evidence of such difference. Pneumonia remains a common side effect for all of them,” said EMA.

“The Committee’s view is that the benefits of inhaled corticosteroids continue to outweigh their risks.” The committee has recommended that product information is now updated “to adequately reflect the current knowledge.”

EMA has said that the findings mean that there will be no change to the way these medicines should be used for the time being. However, it is calling on doctors and patients to be “vigilant for signs and symptoms of pneumonia in patients with COPD as the clinical features of pneumonia overlap with those of exacerbations of the underlying disease.”

Before the recommendation is adopted as the EMA’s final opinion, the PRAC recommendation will be considered by the Committee for Medicinal Products for Human Use (CHMP). “Further details including advice for patients and healthcare professionals will be published at the time of the CHMP opinion,” said EMA.

In a separate EMA announcement, the PRAC has issued advice for doctors and patients using the cancer medicine Zydelig (idelalisib). In particular, it has recommended that patients should receive antibiotics to prevent Pneumocystusjirovecii pneumonia developing. In addition, patients should also be monitored for infection and have regular blood tests for white blood cell counts.

Zydelig can be used in adults with chronic lymphocytic leukaemia (CLL) or who have follicular lymphoma (FL), a form of non-Hodgkin lymphoma.

Links:

EMA inhaled corticosteroids announcement

EMA Zydelig announcement

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