Pharmacovigilance

PRAC News – November 2015

09.11.2015

PRAC 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 available on the HALMED webpages, or here.

Ongoing referrals

During its November meeting, the PRAC discussed two more ongoing referrals.

More information on the PRAC November 2015 Meeting is accessible here.

Back