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

News Category: Regulatory news

Date: 05/11/2015

Reports of adverse drug reactions after HPV vaccination are consistent with what would be expected in this age group

The European Medicines Agency has this afternoon published the outcome of 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 from cervical cancer and other HPV-related cancers and pre-cancerous conditions. This review concluded by consensus 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 to amend the current product information.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) thoroughly reviewed the published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals. As part of this EU review, the PRAC consulted a group of leading experts in the field, and took into account detailed information from a number of patient groups that highlighted the impact these syndromes can have on patients and families. This included information provided by the parents of Irish girls.

Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals. The review found no evidence that the overall rates of these syndromes in vaccinated girls were different from expected rates in these age groups, even taking into account possible underreporting. The PRAC noted that some symptoms of these syndromes may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME). Many of the reports considered in the review have features of CFS and some patients had diagnoses of both POTS and CFS. Results of a large study that showed no link between HPV vaccine and CFS were therefore particularly relevant.

The PRAC concluded that the available evidence does not support that CRPS and POTS are caused by HPV vaccines. Therefore there is no reason to change the way the vaccines are used or to amend the current product information. The review recognised that more than 80 million girls and women worldwide have now received these vaccines and in some European countries they have been given to 90% of the age group recommended for vaccination. Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for tens of thousands of deaths in Europe each year) and various other cancers and conditions caused by HPV. The benefits of HPV vaccines therefore continue to outweigh their risks.

The PRAC’s recommendations will now be passed to the Committee for Medicinal Products for Human Use (CHMP) for adoption of the European Medicines Agency’s final position. The evidence supporting the PRAC review will be published in an assessment report following the CHMP opinion.

The HPRA will, as with all medicines, continue to carefully monitor the safety of these vaccines.

Further information:
European Medicines Agency Press Release

* CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue. In some patients they can severely affect the quality of life. The syndromes are recognised to occur in the general population, including adolescents, regardless of vaccination.

« Back