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Published on 3 June 2010

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FDA orders asthma drug label change

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US health regulators have ordered a number of pharmaceutical companies to change the labelling on controversial inhaled asthma drugs after concerns were raised about their side-effects.

The new guidance, expected since February, says that medicines known as long-acting beta-agonists (LABAs) should never be used on their own.

Food and Drug Administration (FDA) officials said they issued the directive to GlaxoSmithKline, AstraZeneca, Novartis and a number of other smaller firms after some raised doubts that the medication was dangerous.

Dr Badrul Chowdhury, head of the FDA’s pulmonary drugs division, said: “(We are) ordering the involved companies to make labelling changes capturing these new recommendations. Not all of the companies have accepted all the changes … so that’s where the ordering comes in.”

It is not known how long it will take for the new warning to be added to the products.

LABAs relax the muscles of the airways to help people breathe easier, but can also cause severe asthma attacks, the FDA claims.

Copyright Press Association 2010
Food and Drug Administration



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