Fluoxetine - a common antidepressant medication - seems to increase the risk for fractures in stroke

What is it about?

In a large pragmatic study of fluoxetine called FOCUS (Fluoxetine or Control Under Supervision) we showed that fluoxetine did not improve functional outcome measured with the modified Rankin Scale scores. To our surprise, there was an increased risk of fractures in the fluoxetine group (2.9% ) versus 1.5% in the placebo group. The purpose of this exploratory study was to describe the fractures, their impact on the modified Ranking Scale and factors associated with fracture risk. Our analysis showed that the most common site of fracture was the neck of femur, and most were in sites associated with osteoporosis. Almost all fractures were the results of a fall. Our analyses, however, do not support the idea that fractures in the fluoxetine group could explain the lack of improvement in functional outcomes observed in FOCUS. Older age, female gender, and fluoxetine predicted fractures.

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Why is it important?

Our finding that greater age, female gender and fluoxetine are associated with fracture risk is in line with observational studies. The study can not answer why we found this association - it could be due to fluoxetine's effects on cognition and balance, but we cannot rule out a contribution from fluoxetine’s possible effect on bone density.

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