Topiramate - adverse events associated with use to assist with weight loss

Safety advisory

4 October 2011

The TGA has not approved the use of topiramate to assist with weight loss and is advising health professionals and consumers that its use for this indication is associated with serious adverse events.

About topiramate

In Australia, topiramate is only indicated for:

  • the treatment of epilepsy in adults and children aged two years and over
  • the prevention of migraine headaches in adults.

The safety and efficacy of topiramate for any other indication has not been assessed by the TGA.

The potential risks associated with using topiramate include:

  • serious renal (kidney) adverse effects
  • serious ocular (eye) adverse effects
  • decreased effectiveness of hormonal contraceptives
  • disruption of fetal development or congenital (birth) defects when used during pregnancy.

For additional information, please refer to the product and consumer medicines information for topiramate.

The TGA has received a report of a patient who was prescribed topiramate to assist with weight loss, presenting to the emergency department with acute closed angle glaucoma1 soon after commencing topiramate. This is a serious and known side effect of topiramate therapy.

Information for health professionals

Health professionals are encouraged to report any adverse events associated with the use of topiramate, including for off-label2 indications, to the TGA.

The National Health and Medical Research Council, in conjunction with the Department of Health and Ageing, has developed clinical practice guidelines for doctors for the management of overweight and obesity. The three component parts of these guidelines provide a guide for general practitioners and information specific to adults, and to children and adolescents.

Information for consumers

Topiramate is only approved for the treatment of epilepsy or the prevention of migraine headaches and there are serious risks associated with its use to assist with weight loss.

Consumers who experience adverse effects after taking topiramate should seek medical advice.

  • Information on how health professionals and consumers can report a suspected problem with a medicine or medical device to the TGA can be found at 'Reporting Problems'.

References

  1. A rapid increase in the pressure inside the eye due to the iris blocking the drainage of the aqueous fluid. (Source: Glaucoma Australia)
  2. Prescription or use of a medicine for any indication which has not been approved by the TGA. (Source: Therapeutic Goods Administration)