Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016

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18/03/2016

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016

In March, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded one safety review. It also discussed three new safety reviews. For one of these, regarding the cancer medicine Zydelig, the PRAC proposed provisional measures, as a precaution, to protect patients while the medicine is being reviewed.

PRAC concludes the review of the known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease

The PRAC has reviewed the known risk of pneumonia (infection of the lungs) with inhaled corticosteroid-containing medicines when used to treat chronic obstructive pulmonary disease (COPD). Corticosteroids are widely used in the European Union (EU) to treat COPD and are usually taken by inhalation using an inhaler device.

The PRAC review confirms that COPD patients treated with inhaled corticosteroids are at increased risk of pneumonia; however the Committee’s view is that the benefits of inhaled corticosteroids continue to outweigh their risks. The PRAC also checked whether there were any differences in the risk of pneumonia between these products, and did not find conclusive evidence of such a difference. Pneumonia remains a common side effect for all of them.

More information is provided in the table below.

PRAC recommends new safety measures for Zydelig

The Committee started its review of Zydelig (idelalisib) and issued, as a precaution, provisional advice for doctors and patients using the cancer medicine, to ensure that it continues to be used as safely as possible while the review is ongoing.

The European Medicines Agency (EMA) announced the start of this safety review on Friday 11 March, after a higher rate of serious adverse events was observed in three clinical trials, using the medicine in different ways from currently authorised, among patients receiving Zydelig compared with placebo (a dummy treatment). Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma.

For full information on the PRAC's review and provisional recommendations, please see the information in the table below.

PRAC reviews direct-acting antivirals for hepatitis C

The PRAC also started a review of medicines known as direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). The review follows cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C. Hepatitis B re-activation refers to a return of active infection in a patient whose hepatitis B infection had been inactive.

More information is provided in the table below.

PRAC reviews gadolinium contrast agents used in MRI scans

The Committee started a review of the risk of gadolinium deposition in brain tissue following the use of gadolinium contrast agents in magnetic resonance imaging (MRI) scans. Gadolinium contrast agents are diagnostic products that may be given to patients before or during MRI scans to help doctors obtain better images of organs and tissues.

More information is provided in the table below.

Agenda

 
Agenda - PRAC draft agenda of meeting 14-17 March 2016

  

Start of referral procedure

Direct-acting antivirals for treatment of hepatitis C (interferon-free)

Article-20 referral: Direct-acting antivirals for treatment of hepatitis C (interferon-free)

 

Review started
Referral notification
PRAC list of questions
Timetable for the procedure

 

Gadolinium-containing contrast agents

Article-31 referral: Gadolinium-containing contrast agents

 

Review started
Referral notification
PRAC list of questions
Timetable for the procedure
Annex I

 

Zydelig

Article-20 referral: Zydelig

 

EMA recommends new safety measures for Zydelig

Review started
Referral notification
PRAC list of questions
Timetable for the procedure
Annex III

 

Recommendation by PRAC

Inhaled corticosteroids

Article-31 referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

 

Summary of PRAC recommendation

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