Inquiry into cold cures link to strokes

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An urgent investigation into the safety of a drug found in cold remedies was launched last night after American authorities said it was linked to strokes.

An urgent investigation into the safety of a drug found in cold remedies was launched last night after American authorities said it was linked to strokes.

The Food and Drug Administration intends to make the sale of the drug phenylpropanolamine (PPA) illegal in the United States and some manufacturers have already withdrawn it from shops.

It remains on sale in Britain but the Government asked the Medicines Control Agency last night to carry out an urgent review of its safety. Cold remedies available in Britain containing the drug include Benylin Day and Night, Sinutab, Contac 12-hour cold capsules, and Mucron.

SmithKline Beecham has withdrawn the brand of Contac containing PPA in the US but said it was not doing the same here because limits on cough medicine dosages were lower in Britain.

The Department of Health said the amount of PPA used in cold remedies in Britain was also lower than in the US.

PPA works as a decongestant in cough and cold remedies but is also used as an appetite suppressant in diet drugs.

The FDA asked companies to voluntarily withdraw it ahead of a ban after a Yale University study found it was tied to "very rare" cases of strokes in adults under 50, particularly women.

Charles Ganley, the head of the FDA's division covering over-the-counter drugs, said: "We do believe there is some association between [PPA] and the risk for this event. We don't want to be alarmist. It is a very rare occurrence, but when you develop it, it could be devastating." He said it could cause disability or death.

The FDA estimates PPA might cause between 200 and 500 haemorrhagic strokes a year in patients between 18 and 49. The strokes, involving bleeding into the brain, occurred within three days of people taking PPA products.

A Department of Health spokesman said: "We are aware of the FDA's findings but the situation in the UK is very different because the amount of this ingredient in UK products is much lower than in the States. However, we have asked the Medicines Control Agency to urgently review the safety of PPA and discuss it with the Food and Drug Administration." Anyone with concerns about a medicine was advised to contact their pharmacist.

SmithKline Beecham uses PPA in one of six types of Contac in the US. It has now stopped production and asked retailers to remove it from their shelves.

Other companies were reviewing the FDA announcement and making individual decisions, according to the Consumer Healthcare Products Association (CHPA).

A spokesman for SmithKline Beecham said the Contac product containing PPA was not being withdrawn in the UK because market conditions were different.

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