Painkillers: powerful drugs with important adverse effects

A new report in the Lancet from the Oxford Clinical Trials Unit provides an update on potential risks from newer and traditional painkillers of the non-steroidal anti-inflammatory drug type. The report analysed results of a large number of clinical trials comparing these painkillers against placebo or against a comparator different painkiller. Studies were largely of high doses of the drugs, prescribed for relatively short duration - on average for under a year.

Below is a summary of my comments on the Lancet article provided to the Science Media Centre.

"In this pooled assessment (meta-analysis) of a large number of clinical trials against placebo or other pain-killer options, the Oxford Clinical Trials Service Unit confirm previous reports that the newer pain-killer drugs – coxibs - are associated with a clinically important increase in risk of coronary disease.

"Their major new finding is that among traditional non-steroidal anti-inflammatory painkiller drugs [tNSAIDs] – diclofenac, and possibly ibuprofen, but not naproxen appear associated with a similar increase fatal and non-fatal coronary heart events to the coxibs. However all naproxen, like all coxibs and tNSAIDs they studied, was associated with increased risk of heart failure and gastro-intestinal complications such as bleeding.

"The type of vascular risk with these painkillers appeared selective as none of these treatments were associated with an increase in stroke risk.

“Cautions include that we are not told about details of adjustments across treatment groups for degree of different cardiovascular risk factors e.g. from smoking as a source of bias. And the authors themselves acknowledge that their findings are largely for high dose tNSAIDs and for treatment on average for under a year. They note that they therefore cannot be sure whether the reported coronary and other risks would persist in patients on longer term treatment or on lower doses of these medicines.

“The paper underscores a key point for patients and prescribers: powerful drugs may have serious harmful effects. It is therefore important to be cautious when considering use of these medicines and to take into account cardiovascular risk, and risk of stomach or intestinal adverse effects, when tNSAIDs are prescribed or obtained over the counter, and when coxibs are considered.”

Many patients taking these tablets rely on them for relief of symptoms from arthritis and other long-term painful conditions. Patients who are concerned should consult their medical or pharmacist adviser.

See also articles by reporters on BBC Health, Reuters, Agence France Presse, CBS News ...