FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

EMA: HPV Vaccines Not Linked to CRPS or POTS

Nov. 12, 2015
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee determined that evidence does not support a causal link with HPV vaccines and complex regional pain syndrome and postural orthostatic tachycardia syndrome in young women.

The review included GSK’s Cervarix and Merck’s Gardasil/Silgard and Gardasil-9, and it concluded that there was no reason to change the way the vaccines are used or to amend labeling.

Reviewers noted that reports of CRPS and POTS after HPV vaccination are consistent with what would be expected in women ages 10 to 19, and that the benefit in preventing cervical cancer outweighs the risks.

The PRAC’s recommendations will be passed to the Committee for Medicinal Products for Human Use, and the review will be published in an assessment report following the CHMP opinion.