Lyrica (Pregabalin): Thousands of deaths?

Last Updated on March 28, 2024 by Joseph Gut – thasso

March 27, 2024 – Lyrica (Pregabalin) is a drug from the group of gabapentinoids and is an anticonvulsant active ingredient. It has been approved throughout the EU since 2004 for the treatment of neuropathic pain, epilepsy and generalized anxiety disorder. There are now worrying reports of patient deaths associated with the prescription Lyrica (pregabalin) in the UK. What’s behind it?

According to an investigation by The Sunday Times, the UK’s Office for National Statistics recently published the latest figures on deaths associated with the use of the drugs gabapentin (Neurontin® and generics) and pregabalin (Lyrica® and generics) in England and Wales between 2018 and 2022.

According to this, almost 3,400 deaths have been linked to the active ingredient pregabalin in the past five years. While the number was nine deaths in 2012, ten years later it rose to almost 780 in 2022. According to the Sunday Times, this is the fastest-rising number of drug-related deaths in the UK.

Of course, these numbers also worry users in other countries, and media in various countries have picked up on these numbers; Because the numbers quoted vary and different reports may be based on different sources, there appears to be a problem with pergabalin (and possibly also with gabapentin). As mentioned, the two gabapentinoids are used for neuropathic pain, epilepsy and generalized anxiety disorders and are among the frequently prescribed medications. If used correctly in accordance with the approval of the active ingredients by the responsible licensing authorities (such as FDA, EMA, Swissmedic), there is actually no cause for concern. However, these approvals are often based on clinical trials with potentially small and carefully selected pre-selected numbers of patients. If these drugs are now used in the general patient population, previously unknown behavior and effects (desirable or undesirable) may occur. These are recorded in pharmacovigilance, reported to the registration authorities and stored in databases.

Such pharmacovigilance data may reveal a certain behavior of gabapentins in the population and contribute to understanding the increasing number of fatalities attributed to gabapentin and pergabalin. In the years under discussion, the volume of prescriptions has apparently increased enormously. Although pregabalin is not dangerous in itself, pregabalin could become dangerous when taken with other medicines with which it has negative interactions, regardless of whether it is used as directed or not. There have already been previous warnings regarding abuse, addiction and suicide attempts. In the US, such warnings, issued by the FDA on gabapentin and pregabalin approved in the US for treatment of a variety of neurologic conditions including seizures, nerve pain, and restless legs syndrome, concerned the risk of potentially fatal respiratory depression with this class of drugs.

Interactions with opioids and benzodiazepines.

This also seems to be the problem. An analysis of the figures for gabapentinoid deaths in England between 2004 and 2020 was published in the British Journal of Clinical Pharmacology in April 2022. The deaths following gabapentinoid consumption in England, which were reported to the National Program on Substance Abuse Deaths (NPSUM), were examined in more detail. A total of 3051 deaths were reported (gabapentin: 913 cases; pregabalin: 2322 cases [both detected in 184 cases]). Prescription and illicitly obtained gabapentinoids accounted for a similar proportion of deaths (illegal gabapentin 38.0%, prescribed 37.1%; illicit pregabalin 41.0%, prescribed 34.6%). Opioids were co-discovered in most cases (92.0%) and co-prescribed in a quarter (25.3%). Postmortem blood gabapentinoid concentrations were often (sub)therapeutic (65.0% of gabapentin cases; 50.8% of pregabalin cases). Gabapentinoid toxicity alone was considered the cause of death in only two cases. Gabapentinoids alone rarely cause death. However, clinically relevant doses may prove fatal, possibly by reducing opioid tolerance.

Gabapentin and especially pregabalin only become a life-threatening problem if they are used improperly and in combination with other drugs, especially opioids. Prescribers and patients should be better informed about the potential risks of pregabalin and gabapentin, especially the potential for dependency. Prescribers should regularly check whether the prescription is still necessary. In addition, interactions should be taken into account, especially in the case of an addiction. People at risk of addiction need more support and education.

This appears to be particularly important for patients on pregabalin therapy. Pregabalin was originally marketed for the treatment of epilepsy. The medicine is now also prescribed for anxiety and nerve pain. The list of side effects is long. Dizziness, forgetfulness or even shortness of breath can occur. And particularly problematic: the drug triggers a euphoric mood and can be addictive. The result: addicts can no longer control the intake of the active ingredient and often increase the dose on their own initiative. Or combine the drug with other narcotics – with fatal or fatal consequences. According to those affected, withdrawal from pregabalin is comparable to that of morphine: you go through hell.

Switzerland: Only 17 suspected deaths

The active ingredient pregabalin is also approved in Switzerland to treat epilepsy, nerve pain and anxiety disorders. However, figures from the supervisory and licensing authority Swissmedic show: Pregabalin alone does not lead to an increase in deaths. According to Swissmedic, a total of 17 reports of suspected deaths have been received since 2005. The numbers are stable. There was neither an increase in reports nor were there any noticeable abnormalities. But here too, prescriptions of pregabalin have increased. A study published in 2020 by the Federal Office of Public Health (BAG) came to the conclusion that not only did consumption increase significantly, but the number of treatment days also increased. This also increases the possibility of misuse.

However, the situation in Switzerland seems to be less dramatic than in Great Britain, which could be due to the very different socio-economic situation in Switzerland, without megacities and with a very well-developed social system and expertise in addiction care.

Conclusion

Gabapentins such as Gabapentin (Neurontin and generics) and Pregabalin (Lyrica and generics) are quite difficult drugs to use with a high potential for undesirable interactions with co-medication in the area of addiction. The reports appearing in the media about increasing numbers of fatalities/deaths caused by pregabalin must be put into perspective in that the connection between these cases and co- and multi-medications with addictive potential does not appear in these reports. This can lead to false fears and panic for affected patients about the real extent of the dangers posed by therapies with gabapentins without co-medication.

Here you can see a sequence on various aspects of pregabalin therapy:

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