Seven metered-dose inhalers to treat asthma and COPD will be phased out
The US Food and Drug Administration (FDA) is to remove seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) from the US market.
The inhalers, which contain ozone-depleting chlorofluorocarbons (CFCs), will be gradually phased out.
Alternative medications that do not contain CFCs are available.
The seven inhalers are: the Tilade inhaler (nedocromil), made by King Pharmaceuticals (last date for sale 14 June); the Alupent inhalation aerosol (metaproterenol), made by Boehringer Ingelheim (last date for sale 14 June); the Azmacort inhalation aerosol (triamcinolone), made by Abbott Laboratories (last date for sale 31 December); and the Intal inhaler (cromolyn), made by King Pharmaceuticals (last date for sale 31 December).
The Aerobid inhaler system (flunisolide), made by Forest Laboratories, will be withdrawn from sale on 30 June 2011.
The Combivent inhalation aerosol (albuterol and ipratropium in combination), made by Boehringer Ingelheim Pharmaceuticals and the Maxair Autohaler (pirbuterol), made by Graceway Pharmaceuticals, will both be withdrawn from sale on 31 December 2013.
Four of the seven inhalers are no longer being made. Three CFC inhalers currently in use – the Aerobid, Combivent and Maxair – will be phased out over the next one to three years.
The US has banned the general use of CFCs in consumer aerosols for decades, and eliminated the production of CFCs on 1 January 1996, except for certain limited uses, such as MDIs.
‘During this transition, the FDA wants to ensure that patients have access to safe and effective alternative medications to treat their asthma or COPD,’ said Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA’s Centre for Drug Evaluation and Research.
‘We are currently working with professional societies and patient organisations to make sure patients understand which products will no longer be available and have information on which alternative medication might work best for them.’
The CFC phase-out is part of an international agreement to ban substances that deplete the Earth’s ozone layer.