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Drug regulator announces bisphosphonates safety review



By Lilian Anekwe

The European drug regulator has announced an investigation into a link between the prescribing of bisphosphonates for osteoporosis and stress fractures.

The European Medicines Agency has been alerted to suggested class-related increase in atypical stress fractures, it announced last week.

The agency has asked its Committee for Medicinal Products for Human Use to investigate a ‘possible increased risk of atypical stress fractures in patients taking bisphosphonate-containing medicines for the treatment and prevention of bone disorders’.

This follows an EMA review of published literature and post-marketing reports, which suggested that atypical stress factures might be a class effect of bisphosphonates.

A warning about atypical stress fractures of the proximal femoral shaft has been included in the product information for alendronate-containing medicines across Europe, since a review in 2008.

A statement from the EMA said the review will look at ‘all available data thoroughly, including published data, non-clinical and clinical data and post-marketing reports, to clarify whether atypical stress fractures are a class effect of bisphosphonates, and will assess their impact on the balance of risks and benefits of these medicines’.

The EMA is investigating alendronate-containing medicines