EMA concludes HPV vaccines do not cause CRPS or POTS
pharmafile | November 9, 2015 | News story | Sales and Marketing | EMA, HPV, HPV vaccine, PRAC, complex regional pain syndrome, drug safety, postural orthostatic tachycardia syndrome
The European Medicines Agency says there is no evidence from a detailed scientific review of reports linking complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines.
The vaccines are given to protect from cervical cancer, other HPV-related cancers and pre-cancerous conditions. The review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the evidence does not support a causal link between the vaccines and development of CRPS or POTS.
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.
Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals. However, available estimates suggest that in the general population, around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.
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 CRPS and POTS may overlap with chronic fatigue syndrome.
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 amend the current product information.”
The PRAC’s recommendation will now be reviewed by the CHMP in the comings days. The procedure ends once the European Commission issues a final decision.
Following the publication of the report, Sanofi Pasteur MSD UK says it ‘welcomes the recommendations’, adding: “We welcome this rigorous, scientifically based evaluation of the safety profile of these vaccines that has included published research, clinical trial data, adverse event reports and input from leading experts and patient groups.”
Yasmita Kumar
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