(Reuters Health) – A class of drugs used for nerve and muscle pain, including the popular drug Lyrica, increases the risk of suicidal behavior, unintentional overdoses, injuries and car accidents – and the risks are particularly high for teens and young adults, new research shows.
Lyrica (pregabalin) and the older drug gabapentin, collectively known as gabapentinoids, are approved for the treatment of several types of pain and for the prevention of seizures in patients with epilepsy. The prescription of these drugs has increased sharply in recent years, while off-label use, i.e. for a condition other than the approved indication, is extremely common, write Dr Seena Fazel of the University from Oxford in the UK and his colleagues in the BMJ.
There is some data linking these drugs to an increased risk of suicidal behavior and death from overdose, the authors note, but the evidence is mixed and comes from small studies.
Fazel’s team looked at Swedish registry data on 191,973 people aged 15 and older who were prescribed pregabalin or gabapentin in 2006-2013. During this period, 5.2% were treated for suicidal behavior or died by suicide, 8.9% had unintentional overdoses, 6.3% had serious car accidents resulting in emergency hospitalization or death or were arrested or convicted for a traffic violation, 36.7% had head or body injuries and 4.1% were arrested for violent crimes.
Compared to when the same people were not taking gabapentinoid medication, their risk while taking pregabalin or gabapentin was 26% higher for suicidal behavior or suicide, 24% higher for accidental overdose, 22% higher for head or body injuries, and 13% higher for car accidents and traffic offences.
When the authors looked at the drugs separately, they found that pregabalin was associated with higher risk, but gabapentin was associated with reduced risk or no change in risk.
In a statement emailed to Reuters Health, Lyrica’s manufacturer, Pfizer, said: “When prescribed and administered appropriately according to the approved label, Lyrica (pregabalin) is an important treatment option. and effective for many people. The clinical effectiveness of this drug has been demonstrated in a large number of robust clinical trials with thousands of patients.
“These drugs clearly have a role if used in people who have clear indications for their use,” Fazel agreed. Still, he told Reuters Health in a phone interview: ‘We need to be more careful about how these drugs are prescribed and I think at the very least we should review the guidelines on their use just to make sure that these guidelines are up to date with the latest evidence”.
In an email interview, Dr. Derek K. Tracy of Queen Mary Hospital, who wrote an editorial accompanying the study, said: “This very large trial provides important information that pregabalin – but not gabapentin – increased the risk of a range of adverse outcomes, including suicidal thoughts and completed suicides, head trauma and motor vehicle accidents The risk was ‘dose related’, it that is, the more one takes, the more likely these results are, and young people between the ages of 15 and 24 seem particularly susceptible.
While it’s unclear why the prescription for gabapentinoids has increased so rapidly, Tracy said, “it appears that many physicians consider them to be relatively effective and with a low side effect profile.” As we have accumulated more information over time it has become clear that this is not the case, and more recently there has been a campaign of struggle to try to reduce their use to as their harm profile became more evident.
He added: “It is also becoming increasingly clear over time that some people are becoming addicted (‘addicted’) to gabapentinoids, although we still lack good information on their exact frequency or the groups of people who might be more vulnerable to this. ”
The Wellcome Trust helped fund the study.
SOURCE: bit.ly/2WL3h7P BMJ, online June 12, 2019.