Other safety alerts
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| European Union: EMA to further clarify safety profile of human papillomavirus (HPV) vaccines |
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The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is expected to prevent many cases of cervical cancer (cancer of the neck of the womb) and various other cancers and conditions caused by HPV. Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early. The review does not question that the benefits of HPV vaccines outweigh their risks.
As for all licensed medicines the safety of these vaccines is monitored by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and 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).
Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established. Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected. In its review the PRAC will consider 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 will decide whether to recommend any changes to product information to better inform patients and healthcare professionals. While the review is ongoing there is no change in recommendations for the use of the vaccine.
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 in both 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 (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 worldwide.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002365.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are three registered pharmaceutical products containing human papillomavirus, namely Gardasil Vaccine Inj (Vial) (HK-54934) and Gardasil Vaccine Inj (Pre-filled syringe) (HK-54935) which are registered by Merck Sharp & Dohme (Asia) Ltd; and Cervarix Vaccine (Pre-filled syringe) (HK-56180) which is registered by GlaxoSmithKline Limited. All products are prescription-only medicines. So far, the Department of Health (DH) has received 11 cases of adverse drug reaction on human papillomavirus vaccines, and none of them is related to CRPS and/or POTS. The DH will remain vigilant on the conclusion of the review by the EMA and safety updates by other overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Tuesday, July 14, 2015
Issued at HKT 13:00
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