Pregabalin: How long will we allow this to continue?

The European Medicines Agency should speed up the release of CSRs—they might not be available until 2050.

Deaths related to the use of pregabalin (Lyrica®) are again hitting the headlines: Nearly 3,400 deaths attributed to its use, reported the Times. The Daily Mail reports it is “prescribed to more than eight million people in Britain. “ Before we move on, TTE thinks the Mail meant to say more than 8 million annual prescriptions (Open Prescribing reports 775 thousand items a month).

The drug came from nowhere to be a blockbuster. Increasing awareness of the risks associated with opioid use led to alternatives to reduce the risk of dependence. Gabapentin and pregabalin emerged to fill the void, and their use has gradually increased. At one point, it was the second most expensive drug in the NHS drug budget for England.

Pregabalin was approved in Europe over a decade ago for the treatment of generalised anxiety disorder. However, it hasn't been FDA-approved for this indication: In 2009, the FDA determined that the data contained in the New Drug Application were insufficient to support approv…