Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Thursday, July 21, 2011

Glaxo's Pandemrix Vaccine Restricted Use Review



The European Medicines Agency [EMA] today issued a press release regarding GlaxoSmithKline's Pandemrix vaccine. It's more bad news for Glaxo as the EMA have decided to restrict its use in children and teenagers because of a link to narcolepsy.

Narcolepsy is a chronic sleep disorder, or dyssomnia, characterized by an excessive urge to sleep at inappropriate times and in Finnish and Swedish studies there was a 6- to 13-fold increase risk of narcolepsy in young people who had received the Pandemrix vaccine.

The EMA have recommended a labeling change that limits the vaccine's use in children and teens to when protection is needed and seasonal trivalent vaccine isn't available. In other words, it won't be used as a first line treatment.


GSK have issue a press release on their webpage, the end paragraph is classic:

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Pardon the pun but...Zzzzzzzzzzzzz

Fid

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