Older painkillers linked to heart attack risk
pharmafile | June 14, 2005 | News story | Sales and Marketing |Â Â Â
Two widely used painkillers ibuprofen and naproxen have been linked to increased rates of heart attacks in patients, a new UK study suggests.
A number of expert groups have doubts about the conclusions of the study, but the news is a further blow to the image of non-steroidal anti-inflammatory drugs (NSAIDs) following safety concerns emerging around Cox-II inhibitors.
Researchers studied records of over 9,200 UK patients who had suffered their first heart attack and compared this against use of NSAIDs, including the newer Cox-IIs.
The study concluded the older NSAID, naproxen, may have caused even more heart attacks than Vioxx (rofecoxib), the drug Merck was forced to withdraw in September 2004 because of these side-effects.
Ibuprofen, another older NSAID very widely used, was also found to increase heart attacks, although less frequently than in either naproxen or Vioxx.
Many experts, including the BMJ which published the paper, said the results should be interpreted with caution, but the findings have nevertheless concerned patient representatives.
The MHRA has not altered its guidance to doctors in light of the study, saying only that evidence relating to the traditional NSAIDs is "less clear" than that on the Cox-II class.
A Europe-wide review of the older NSAIDs is now under way, but until its findings are published the MHRA is restating advice that the lowest effective dose should be used for the shortest period possible.
The withdrawal of Merck's Vioxx, and more recently the marketing suspension of Pfizer's Bextra because of safety fears, has prompted a large scale drop in the use of existing Cox-IIs, often in favour of the older NSAIDs.
Now patient groups say arthritis and other patients will be confused and frightened, with apparently no major painkiller medication free from suspicion of serious side-effects.
Neil Betteridge, chief executive of Arthritis Care said the study represented "further depressing news" for people with arthritis following the withdrawal of Vioxx and co-proxamol and said there was a great deal of confusion and concern about medicines for the painful condition.
"We urgently need the medical profession to take a lead in helping people with arthritis decide what treatment is right for them. Of course, any medicine that brings a benefit is likely also to carry a risk of some side-effects. Indeed, doing nothing to manage your condition may also carry a risk. However, there needs to be very clear communication of both the risks and benefits associated with each and every treatment. Ultimately, it is the person with arthritis who will decide what to take for their condition and their decision needs to be an informed one."
Pharmacist organisation the RPSGB was one of many groups who expressed serious doubts about the study and the methodology used, known as nested case control, which it said is "fraught with difficulties".
It points out that data on whether or not the patients were smokers or obese was missing in as much as 28% of patients – key factors which could confound the results, if known.
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