Glaxo made to drop Paxil ads after US ruling

GlaxoSmithKline has been forced to drop US adverts for its biggest-selling drug, the anti-depressant Paxil, after a court in Florida ruled they could be misleading.

GSK said it would appeal against the judgment, which bans its adverts for the duration of a trial in which a group of users claim it is addictive.

The court ruled the adverts were creating inaccurate expectations about the ease of withdrawal from the drug, after the "plaintiffs have demonstrated that, at least for some patients, there is more than a mere possibility that severe reactions can accompany a withdrawal from Paxil".

Paxil, which is sold as Seroxat in Europe, is facing legal assaults from all sides in the US. Groups of users continue to pursue legal actions claiming it is addictive, and that the drug causes withdrawal symptoms such as shaking, nausea and insomnia that are often misdiagnosed by doctors as a relapse into depression.

Meanwhile, makers of unbranded, or generic, drugs claim GSK's patents on the drug are invalid and they should be allowed to manufacture cheap copies.

GSK sold £5m a day of Paxil last year, but there are fears the negative legal publicity could be discouraging new users. GSK said it hoped to overturn the Florida ruling, which it said created a worrying precedent for court intervention into the way drugs are marketed.

David Stout, president of US pharmaceuticals at GSK, said: "The US Food & Drug Administration – and not the courts – has the expertise and responsibility for reviewing and regulating pharmaceutical ads. The Paxil ad was submitted for FDA review prior to use, and the agency raised no objections to the language at issue."

GSK insisted the ruling made it no more likely that the courts will agree that Paxil is habit-forming, but the ruling led to a 2.5 per cent fall in the GSK share price yesterday to 1,336p, more than 30 per cent lower than a year ago.

It is the latest setback for the company, which in June began to face generic competitors to Augmentin, its biggest selling drug, and which is facing questions over the quality of its pipeline of new drugs.