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Monday 28th May 2018

FDA issues notice on RotaTeq

15th February 2007

A public health notice to health professionals and consumers has been issued by the FDA concerning the rotavirus vaccine RotaTeq.

This follows 28 reports on infants getting intussusception after being vaccinated with RotaTeq since February last year, when the vaccine was licensed. RotaTeq is manufactured by Merck, and so far 3.5 million doses of RotaTeq have been distributed in the United States, however not all have yet been administered.

Rotavirus gastroenteritis is the major cause of diarrhoea and vomiting in young children all over the world. It is highly contagious and can cause severe dehydration and in some cases death.

However the FDA is issuing the warning because intussusception is a potential complication of the RotaTeq vaccine; intussusception is a serious life threatening condition causing part of the bowel to collapse into a neighbouring part, resulting in the bowel becoming blocked or twisted.

The FDA note however that intussusception can occur spontaneously without vaccination - the 28 reported cases may have been caused by RotaTeq or by coincidence. Half of the reported cases occurred within 21 days of vaccination.

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