FiercePharma

GSK adds bowel risk to Rotarix label

Some evidence has cropped up indicating that GlaxoSmithKline's infant vaccine Rotarix may boost the risk of a rare but potentially fatal bowel problem. It's intussusception--a condition in which the ...
Los Angeles Times

The FDA warns against using Rotarix rotavirus vaccine--at least temporarily

This article was originally on a blog post platform and may be missing photos, graphics or links. See About archive blog posts. The Food and Drug Administration on Monday warned doctors and parents ...
streetinsider

U.S. FDA Recommends Clinicians Temporarily Suspend Use of Rotarix Vaccine (GSK)

FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an ...
Medscape

Rotarix or RotaTeq Vaccination May Be Effective, Safe in Childhood

May 17, 2010 — Rotarix (GlaxoSmithKline) and RotaTeq (Merck) vaccination may be safe and effective at preventing rotavirus disease in childhood, according to the results of a review reported online ...
FiercePharma

ALSO NOTED: GSK gains Rotarix approval; Bavarian Nordic touts smallpox data; and much more...

GlaxoSmithKline has received FDA approval for Rotarix, a vaccine to stop the leading cause of diarrhea. The approval opens the way for a direct competitor to Merck's RotaReq. Rotarix requires only two ...
Monthly Prescribing Reference

New Formulation of Rotarix Removes the Need for Reconstitution

The new liquid formulation of Rotarix does not require reconstitution or dilution before use. The Food and Drug Administration (FDA) has approved an oral-dosing applicator-only presentation (liquid ...
clinicaladvisor.com

Rotarix just as effective as Rotateq against rotavirus

Rotarix on par with Rotateq for rotavirus gastroenteritis The monovalent rotavirus vaccine is more than 90% effective at preventing rotavirus, putting the vaccine's efficacy on par with the ...
Sydney Morning Herald

Agency says Rotarix vaccine is safe

The European Medicines Agency says the presence of pig virus in GlaxoSmithKline's Rotarix vaccine poses no threat to human health and can continue to be safely used. However, the European's Union ...
irblog.prnewswire.com

GlaxoSmithKline Statement on New Information Relating to Manufacture of Rotarix (Rotavirus Vaccine)

LONDON, March 22 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today confirmed that it has notified regulatory authorities of the presence of material from a ...
Monthly Prescribing Reference

Rotarix vaccine approved for rotavirus prevention

The FDA has approved Rotarix (live oral rotavirus vaccine, from GlaxoSmithKline) for the prevention of rotavirus gastroenteritis in infants. Rotarix offers protection against the most commonly ...
Medscape

FDA Says Use of Rotarix Should Resume

May 14, 2010 (UPDATED May 18, 2010) — The US Food and Drug Administration (FDA) announced today that it is revising its recommendations for rotavirus vaccines. The agency says that based on a careful ...