GLAXOSMITHKLINE is facing scores of legal actions in the US over the sale of cold remedies that are claimed to have caused strokes and other severe side-effects.
GSK and other drug manufacturers are being targeted after a massive drug recall of products containing phenylpropanolamine (PPA).
The first of a series of legal actions which could cost the industry billions of dollars have already started in Alabama and New Jersey.
The suits come seven months after a report by Yale University claimed PPA had caused 500 strokes and four deaths. This report led the US Food & Drug Administration (FDA) to ban all over-the-counter products containing PPA. A massive product recall resulted in nearly 300 products - mostly cold remedies or diet products - being removed from US pharmacists.
In the UK, though, PPA-based remedies are still on sale. The Medicines Control Agency has decided that the link between PPA and strokes is weak and that as UK drugs typically contain only two- thirds of the PPA dose used in the US, they were less dangerous.
Despite this, Boots has stopped the manufacture of cold remedies containing PPA. However, GSK and other drug majors are still offering PPA products in Britain.
Lawyers in the US allege that the drug giants knew of the dangers of PPA. "Despite this knowledge, for years, defendants used PPA in many non- prescription, over-the-counter cold, flu and sinus medications," say court papers filed in the northern district of Alabama last week in an action against GSK.
So far, 290 common cough remedies have been found to be potentially hazardous. Some 4.5 billion doses of remedies containing PPA were sold in 1999.
The FDA has been concerned …