NSAID Info

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Studies Show Potential GI Risks With Over-The-Counter NSAIDS

LONDON, ENGLAND -- Sept. 10, 1998 -- New preliminary research presented

at the World Congress of Gastroenterology in Vienna this week has

highlighted the potential risk of serious gastrointestinal (GI) side

effects with over-the-counter non-steroidal anti-inflammatory drug

(NSAID) pain relievers like aspirin and ibuprofen.

Stomach bleeding is a well-known side effect of prescription strength

NSAIDs but this data indicates that GI bleeding can occur even with the

low doses used in OTC preparations. By contrast the research

demonstrated that the non-NSAID acetaminophen is not associated with

this potentially life-threatening effect.

Dr. Gurkirpal Singh and co-workers from Stanford University in

California studied serious GI toxicity of aspirin, ibuprofen, naproxen

and acetaminophen in OTC doses and compared them to patients who

received no drug therapy.

The study involved 4,164 patients (the equivalent of 6,279 patient

years) in consecutively diagnosed rheumatoid arthritis patients from

eight centres in North America. Serious GI events were defined as GI

bleeding and other clinically-significant GI events requiring

hospitalisation.

The results show that patients taking OTC doses of NSAIDs were nearly

four times more likely to suffer from GI bleeding or hospitalisation

than those taking no drug. The results also demonstrated that

acetaminophen did not show any significant difference in the risk of GI

bleeding compared to no treatment.

" While the risk with OTC NSAIDs is lower than that seen with

prescription doses, this is the first time this risk has been seen with

the lower OTC doses which are freely available to consumers, " Dr. Singh

said. " The data is clinically significant and a matter of serious

concern because of the widespread use of these medications and an

under-appreciation of the risk.

" All the OTC NSAIDs that we reviewed had similar levels of toxicity. The

study did not find any increased risk of serious GI side effects in

patients taking acetaminophen. "

Another important study presented at the same conference also quantified

the potential risks of GI bleeding associated with the use of OTC

analgesics. Researchers from the International Epidemiology Institute in

land, using data collected by the American College of

Gastroenterology (ACG), assessed information on recent use of multiple

analgesics, plus data on tobacco, alcohol and other factors for 627

patients enrolled in the ACG's GI Bleeding Registry and in 590 matched

controls.

The risk of GI bleeding increased 2 to 3 fold among recent users of OTC

doses of aspirin, ibuprofen or other NSAIDs, with greater increases

among heavy pill users. In contrast, no increased risk was found among

acetaminophen users.

" While these findings are preliminary, they point to potentially serious

side effects which, given the widespread use of these OTC pain

relievers, suggests the need for further confirmatory studies, " said Dr.

Blot of the International Epidemiology Institute.

Lyn

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