Home » Hundreds of deaths in England: Pregabalin remains available in Germany

Hundreds of deaths in England: Pregabalin remains available in Germany

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Hundreds of deaths in England: Pregabalin remains available in Germany

Given the reports from Great Britain, is the drug still safe? iStock/Getty Images Plus

The drug pregabalin, which is prescribed for epilepsy or anxiety disorders, is thought to be linked to hundreds of deaths in Britain.

Pregabalin is also used in Germany. In the first three quarters of 2023, pregabalin worth over 140 million euros was sold in Germany, according to data from the National Association of Statutory Health Insurance Funds.

Pregabalin is being “closely monitored,” explains the Federal Institute for Drugs and Medical Devices upon request. However, no further measures will be taken at the moment.

A few days ago, news spread in Germany that, according to the British Office for National Statistics, the drug Pregabalin was related with hundreds of deaths should stand. Pregabalin is used for epilepsy and anxiety disorders. But if the drug is taken together with other medicines, negative interactions can occur. say experts. In rare cases, serious withdrawal symptoms, including suicidal thoughts, may occur when stopping pregabalin.

Pregabalin is also used millions of times in Germany: in the first three quarters of 2023, over 144 million euros were sold with Pregabalin across Germany, as shown by data from the National Association of Statutory Health Insurance Funds. This corresponds to over 100 million recommended daily doses of the drug.

Despite the reports from Great Britain, pregabalin remains available in Germany. Business Insider asked the responsible Federal Institute for Drugs and Medical Devices (BfArM) what risks the drug really poses and what measures have been taken.

A few suspected cases – used millions of times

“Data show a close temporal connection between discontinuation of pregabalin and the occurrence of suicidal thoughts either with or without further withdrawal symptoms,” explains a spokesman for the BfArM upon request. “The BfArM has received a total of 2,941 serious case reports of suspected cases from Germany,” the spokesman explains. However, these are countered by millions of applications.

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“Ten of these cases are cases of completed suicide in which a connection to the use of pregabalin is suspected” – but this has not been proven with certainty. “These figures compare with sales of 5.5 million packs of the drug in 2021.” So is the risk relatively low – and are the UK figures not a cause for concern?

Risks have been known for a long time

From the BfArM’s point of view, “no completely new findings” were published in Great Britain, explains a spokesman in response to a Business Insider request. The issue surrounding the risks of pregabalin has been “under consideration for a long time” and important measures have “already been implemented”. The severe withdrawal symptoms have already been anticipated.

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For example, the European Pharmacovigilance Risk Assessment Committee recommended that “suicidal ideation” be added to the product information as a possible withdrawal symptom. In a leaflet that the BfArM sent to Business Insider, you can see that the warning about the side effects was fully included. The side effect is classified there as “rare”. This means that the side effect can occur in up to one in 1,000 patients.

No stricter rules for pregabalin

However, based on the current reports, they are not so worried that new measures will be taken. In May 2022, a working group was set up to examine whether pregabalin should be subject to the narcotics regulations. The drug would then have been threatened with stricter regulations in the areas of sales, prescription and use. But the experts decided that pregabalin should fall under the stricter regulations.

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However, doctors should be more “sensitized” to the risks of pregabalin, according to the BfArM spokesman.

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