MEDIA STATEMENT

21st December 2006

FDA LABEL WARNINGS

The International Ibuprofen Foundation (IIF) notes the recent Food and Drug Administration (FDA) announcement on stronger label warnings about side effects of widely available analgesics. For NSAIDs which include ibuprofen the FDA believe that new warnings should draw attention to the increased risk of gastric bleeding in people over 60.

The IIF and its members are in continuous communication with regulatory authorities in Europe and elsewhere and consistently comply with their requirements. The main European body is the European Medicines Agency (EMEA) and they have recently issued a statement saying that in reviewing safety aspects of NSAIDs they concluded that there were no new concerns about possible gastrointestinal safety.


As with all medications it is important that the label instructions be strictly followed. People who are concerned about this should consult their doctor or pharmacist for professional advice.

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