Drugs to treat fibromyalgia - the transatlantic difference.

Fibromyalgia is a disorder characterized by chronic widespread musculoskeletal pain and stiffness. In 2007, the US FDA approved pregabalin as the first drug indicated for the management of fibromyalgia. Within 18 months, the agency had also approved duloxetine and milnacipran for the same indication. However, although these drugs are already marketed in Europe for other indications, the European regulatory authorities recently rejected extending approval for these three drugs for the treatment of fibromyalgia. This editorial discusses the possible reasons for this 'transatlantic difference'.