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 Lyrica (pregabalin) and the older drug gabapentin, collectively
known as gabapentinoids, are approved for treating several types of
pain and for preventing seizures in patients with epilepsy.
Prescribing of these medications has increased sharply in recent
years, while off-label use, meaning for a condition other than the
approved indication, is extremely common, Dr. Seena Fazel of the
University of Oxford in the UK and colleagues write in the BMJ.
There's 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 age
15 and older prescribed pregabalin or gabapentin in 2006-2013.
During that period, 5.2% were treated for suicidal behavior or died
from 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 offense, 36.7% had head or body
injuries, and 4.1% were arrested for violent crimes.
Compared to when the same people weren't taking a gabapentinoid
drug, 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 crashes and traffic offenses.
When the authors looked at the drugs separately, they found
pregabalin was associated with a higher risk, but gabapentin was
associated with a decreased risk or no change in risk.
In a statement emailed to Reuters Health, Lyrica maker Pfizer said:
"When prescribed and administered appropriately as per the approved
label, Lyrica (pregabalin) is an important and effective treatment
option for many people. The clinical effectiveness of this medicine
has been demonstrated in a large number of robust clinical trials
among thousands of patients."
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"These medications clearly have a role if they're 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 medications are prescribed and I think at the very
least we should review guidelines about their use just to make sure
these guidelines are up to date with the latest evidence."
In an email interview, Dr. Derek K. Tracy of Queen Mary's 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 suicide thinking and completed suicide, head injuries, and
road traffic accidents. The risk was 'dose-related' which is to say
the more one takes, the more likely such outcomes were, and young
people aged 15 to 24 seem particularly susceptible."
While it's not clear why prescribing of gabapentinoids has grown so
rapidly, Tracy said, "anecdotally it appears that many doctors
regarded them as relatively effective and with a low side effect
profile. As we accumulated more information over time, it has become
clear that this is not the case, and most recently there has been a
countering drive to try reduce their usage as their harm profile
came more to the fore."
He added: "It is also becoming clearer with time that some people
are becoming dependent ("addicted") to gabapentinoids, though we
still lack good information on exactly how common that is, or which
groups of people might be more vulnerable to this."
The Wellcome Trust helped fund the study.
SOURCE: http://bit.ly/2WL3h7P BMJ, online June 12, 2019.
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