The European Medicines Agency (EMA) started a review of HPV vaccines to further clarify aspects of their safety profile.
The review looked at available data with a focus on rare reports of two conditions:
- complex regional pain syndrome (CRPS)
a chronic pain condition affecting the limbs,
- postural orthostatic tachycardia syndrome (POTS)
a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness.
In its review the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) considered the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee decided whether to recommend any changes to product information to better inform patients and healthcare professionals.
- EMA to further clarify safety profile of human papillomavirus (HPV) vaccines, ema press release, 13/07/2015.
- EMA information on Cervarix, Gardasil, Gardasil 9, Silgard vaccines.
EMA concluded this review : HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS.
- EMA press release and full PDF, 12 January 2016.
An official complaint has been filed by the Nordic Cochrane Center against the European Medicines Agency (EMA) over its handling of safety issues concerning human papillomavirus (HPV) vaccines.
In the complaint, which runs to 19 pages, the Nordic group says that the official EMA report is flawed.
- Complaint to the European Medicines Agency (EMA) over maladministration at the EM, Nordic Cochrane Centre, 26 May 2016.
- Complaint Filed Over EMA’s Handling of HPV Vaccine Safety Issues, Medscape Medical News, July 05, 2016.
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