ASMI has moved to reassure patients after a study linked PPIs to a higher risk of death
The study’s authors have suggested it may be time to restrict the indications for use and duration of treatment for PPIs.
An American study, published in BMJ Open, examined the data of more than six million people to compare the risk of death between those taking PPIs or H2 blockers, or neither.
They found those taking PPIs had a 25% increased likelihood of death in a six-year period compared to those taking the H2 blockers, and that the longer someone took PPIs, the more that risk increased.
Recent research has indicated a link between PPI use and a heightened risk of chronic kidney disease/kidney disease progression, dementia, C difficile infections, and bone fractures in people with osteoporosis, the authors say.
Although far from conclusive, emerging evidence suggests that PPIs may boost the risk of tissue damage arising from oxidative stress, as well as the shortening of telomeres.
They obtained data from a network of integrated healthcare systems involving more than 6 million people whose health was tracked for an average of almost six years—until 2013 or death, whichever came first.
As well as the analysis comparing people taking PPIs to those on H2 receptor antagonists, they also performed analyses between users and non-users of PPIs and users of PPIs with people taking neither PPIs nor H2 blockers.
The other analyses revealed a similar level of risk between users and non-users of PPIs and between those taking PPIs and those taking no acid suppressant drugs.
The risk of death was also heightened among those who were taking PPIs despite having no appropriate medical indication for their use, such as ulcers, H pylori infection, Barrett’s oesophagus and oesophageal cancer.
They warn that the study was observational only and no firm conclusions can be drawn about cause and effect; that most participants were older white US veterans, which could limit wider applicability of the findings; and that the researchers were unable to obtain information on the causes of death.
However they said the consistency of the results and growing body of evidence linking PPIs with a range of side-effects were “compelling”.
“Although our results should not deter prescription and use of PPIs where medically indicated, they may be used to encourage and promote pharmacovigilance and emphasise the need to exercise judicious use of PPIs and limit use and duration of therapy to instances where there is a clear medical indication and where benefit outweighs potential risk,” they write.
Following the publication of the study, the Australian Self-Medication Industry said that consumers can have confidence in the safety profile and effectiveness of OTC PPIs when used as recommended.
It pointed out that the BMJ study examined the effect of prescription PPIs, which are typically used at higher doses and for longer durations.
“OTC PPIs are effective for the short-term management of gastro-oesophageal reflux disease, which is characterised by frequent heartburn,” says ASMI regulatory and legal director Steve Scarff.
“They should be used in accordance with the label directions and if consumers have any concerns they should discuss them with their healthcare professional.
“ASMI commends the study for assessing risk in older adults whose conditions require the use of stronger PPIs under medical supervision.
“This study emphasises the value of a quality use of medicines approach – the use of the appropriate medicine for the condition, in the appropriate dose and for the correct duration.”
He says that there is already a “robust” pharmacovigilance system in place for both OTC and prescription products in Australia.