MEDIA STATEMENT

27 June 2005
Re: Changes to the labelling of NSAIDs in the United States

What is the labelling change?
The Food and Drug Agency (FDA), the regulatory authority responsible for medicines in the United States, has ruled that the patient information provided with non-steroidal anti-inflammatory drugs (NSAIDs) should include advice that these medicines may increase the risk of heart attack or stroke1.

This ruling is based on evidence from clinical trials of prescribed NSAIDs, not NSAIDs purchased over the counter (OTC). Consequently, the warnings applied to prescribed NSAIDs are stronger than those for OTC NSAIDs.

The FDA now requires patient information distributed with OTC NSAIDs in the United States to state: taking an NSAID for longer than 10 days, or at more than the recommended dose, may increase the risk of heart attack or stroke2.

This is a precautionary step. Official advice to the FDA acknowledges that3:

• there is no evidence that NSAIDs taken at OTC doses and durations increase the risk of heart attack or stroke
• it is unclear how evidence from long-term clinical trials of high doses of prescribed NSAIDs can be applied to the short-term low-dose use typical of OTC NSAIDs to treat acute pain
• the cardiovascular risk associated with short-term intermittent use of low doses of NSAIDs is very small, if any, in the absence of a predisposing condition (e.g. coronary heart disease)


People who have heart disease are advised to consult their doctor before taking an OTC NSAID. The International Ibuprofen Foundation recommends that ibuprofen should be used after medical recommendation or under medical supervision in such cases.
Who is affected?
The FDA's ruling applies only in the United States and its jurisdiction; it does not apply to the international market.

What do we know about the safety of OTC ibuprofen?
OTC ibuprofen has a long history of wide and safe use. In the studies submitted to regulatory authorities to gain approval for OTC ibuprofen, there was no evidence of an increased risk of serious cardiovascular events in the short-term treatment of acute pain3.

We are aware of fifteen studies that have investigated the use of ibuprofen by people who have had a heart attack. These were observational studies and therefore could only determine whether there was an association between a drug and an effect, not whether the drug caused that effect. Additionally they studied high dose, long-term regular use of ibuprofen rather than low dose, short-term OTC use.

Of these prescription based studies, seven found no link between ibuprofen and the risk of heart attack, five found that ibuprofen was associated with a lower risk and three found it may be associated with an increased risk.
ENDS
References
1. US Food and Drug Administration. COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). www.fda.gov/cder/drug/infopage/COX2/default.htm (accessed 21/6/05)

2. US Food and Drug Administration Department of Health and human Services. Supplemental labelling request - CBE. www.fda.gov/cder/drug/infopage/COX2/NSAIDOTCSuppLTR.pdf (accessed 21/6/05)

3. Jenkins JK, Seligman PJ. Analysis and recommendations for Agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk.www.fda.gov/cder/drug/infopage/COX2/NSAIDdecisionMemo.pdf (accessed 21/6/05)

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