November 5, 2015 / 3:41 PM / 4 years ago

EU regulator finds no safety issues with GSK, Merck HPV vaccines

The signage for the GlaxoSmithKline building is pictured in Hounslow, west London June 18, 2013. REUTERS/Luke MacGregor/Files

LONDON (Reuters) - European drug regulators have found no safety concerns linking GlaxoSmithKline’s and Merck’s cervical cancer vaccines with two conditions known as complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).

Concluding a safety review on Wednesday, the European Medicines Agency said its Pharmacovigilance Risk Assessment Committee (PRAC) found that “evidence does not support a causal link between the vaccines and development of CRPS or POTS”.

“There is no reason to change the way the vaccines are used or amend the current product information,” it said in a statement.

The vaccines - GSK’s Cervarix and Merck’s Gardasil, - are given to girls and young women protect them from cervical cancer caused by the human papillomavirus (HPV) and other HPV-related cancers and pre-cancerous conditions.

More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90 percent of the age group recommended for vaccination, according to the European agency.

It said use of the vaccines is expected to prevent many cases of cervical cancer, which is responsible for tens of thousands of deaths in Europe each year, as well as other cancers and conditions caused by HPV.

“The benefits of HPV vaccines ... continue to outweigh their risks,” it said. “The safety of these vaccines, as with all medicines, will continue to be carefully monitored.”

Reporting by Kate Kelland; Editing by Mark Potter

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