Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-5 November 2015

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-5 November 2015

Review concludes evidence does not support that HPV vaccines cause CRPS or POTS

The PRAC has completed a detailed scientific review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions. This review concluded that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and development of CRPS or POTS. Therefore there is no reason to change the way the vaccines are used or amend the current product information. More information is included in the table below.

Ongoing referrals

During its November meeting, the PRAC discussed two more ongoing referrals. More information on ongoing referrals is included in the table below.

Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting 30 November - 3 December 2015. 



Agenda - PRAC draft agenda of meeting 3-6 November 2015


Recommendation by PRAC

Article-20 procedure: Human papillomavirus (HPV) vaccines

Summary of PRAC recommendation


Ongoing referrals

Article-31 referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary diseaseUnder evaluationPRAC adopted a list of outstanding issues and has updated the referral timetable
Article-20 procedure: TysabriUnder evaluationPRAC adopted of a list of experts for the Scientific Advisory Group (SAG)
Article-20 procedure: SGLT2 inhibitorsUnder evaluationPRAC continued its assessment
Article-31 procedure: Fusafungine containing medicinal products for oromucosal and nasal useUnder evaluationPRAC continued its assessment

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