Other safety alerts
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| European Union: Review concludes evidence does not support that HPV vaccines cause CRPS or POTS |
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (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.
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.
PRAC thoroughly reviewed the published research, data from clinical trials and reports of suspected side effects from patients and healthcare professionals, as well as data supplied by Member States. It also consulted a group of leading experts in the field, and took into account detailed information received from a number of patient groups that also highlighted the impact these syndromes can have on patients and families.
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 (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 published 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 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 safety of these vaccines, as with all medicines, will continue to be carefully monitored.
HPV vaccines are available in the European Union under the names Gardasil/Silgard, Gardasil 9, and Cervarix. Gardasil has been authorised since September 2006, and is approved for use in males and females for preventing precancerous growths and cancer in the cervix and anus, and genital warts. It protects against 4 types of HPV (types 6, 11, 16 and 18). Gardasil 9 (approved in June 2015) is used similarly but protects against 9 types of the virus (types 6, 11, 16, 18, 31, 33, 45, 52 and 58). Cervarix has been approved since September 2007 for use in women and girls to protect against precancerous growths and cancer in the cervix and genital area. It is active against types 16 and 18 of the virus. Following their approval, the vaccines have been introduced in national immunisation programs in many countries. It is estimated that more than 63 million girls and women worldwide have been vaccinated with Gardasil/Silgard and more than 19 million with Cervarix.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002429.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are three registered pharmaceutical products of human papillomavirus (HPV) vaccine, namely Gardasil Vaccine Inj (Vial) (HK-54934) and Gardasil Vaccine Inj (Pre-filled Syringe) (HK-54935) registered by Merck Sharp & Dohme (Asia) Ltd; and Cervarix Vaccine (Pre-filled Syringe) (HK-56180) registered by GlaxoSmithKline Limited. All products are prescription-only medicines. There was previous news on the start of scientific review on HPV vaccines by the EMA, which was posted on the Drug Office website on 14 July 2015. So far, the Department of Health (DH) has received 11 cases of adverse event following immunization of HPV vaccines, and none of them was related to CRPS and/or POTS. In view of the conclusions of the scientific review by the EMA, letters to inform local healthcare professionals will be issued. DH will continue to remain vigilant on the safety of HPV vaccines.
Ends/ Friday, November 06, 2015
Issued at HKT 14:00
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