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MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

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  • MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

    MHRA issues DRUs covering gabapentin, methylprednisolone, clozapine and isotretinoin

    Tuesday, 31 October 2017 20:03
  • PPIs may add to liver disease problems in people with alcohol dependency, suggests study

    PPIs may add to liver disease problems in people with alcohol dependency, suggests study

    Tuesday, 17 October 2017 14:27
  • Pregnant women are not always informed of risks associated with sodium valproate

    Pregnant women are not always informed of risks associated with sodium valproate

    Tuesday, 26 September 2017 14:14
  • Study finds ibuprofen is linked to blood pressure rise in arthritis patients at cardiovascular risk

    Study finds ibuprofen is linked to blood pressure rise in arthritis patients at cardiovascular risk

    Monday, 04 September 2017 15:12
  • Steroids are not effective for chest infection, new study finds

    Steroids are not effective for chest infection, new study finds

    Thursday, 31 August 2017 12:57

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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