Weight loss product warning from TGA

Posted by AFN Staff Writers on 5th October 2011

Australia’s regulatory agency for medical drugs, the Therapeutic Goods Administration (TGA) today warned health professionals and consumers against topiramate, an anti-epilepsy drug, being used for weight loss programs.

In a statement released today, the TGA said it had received a report of a patient who was prescribed topiramate to assist with weight loss. Soon after consuming the product topiramate, the patient was diagnosed with acute closed angle glaucoma. Glaucoma is a serious eye disorder potentially leading to blindness.

In Australia, topiramate is only recommended by the TGA for the treatment of epilepsy in adults and children aged two years and over, as well as the prevention of migraine headaches in adults. The TGA said the safety and efficacy of topiramate for any other use has not been assessed or approved by the TGA.

A spokesperson for the TGA, pointing out the existence of high potential risks of other serious adverse health consequences too, said, “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.”

The TGA is encouraging all health professionals in Australia to report any adverse events associated with the use of topiramate, including for off-label use.

Upcoming Syposium will focus on regulation of TGA products, functional foods and dietary supplements

Australian specialist compliance law firm FoodLegal, in conjunction with the SAI Global group, is conducting a Symposium this coming Monday 10 October 2011 in Sydney to address various regulatory issues that consider such products as weight loss and dietary supplements.

Speakers include a TGA regulatory expert, food regulation experts and senior representatives of government food agency FSANZ and the Australian Competition and Consumer Commission (ACCC).

Pre-booking this week is required to secure a place at the Symposium, titled ‘Healthy Bodies of Law: Food or Therapeutic? Finding Advantages in the Regulatory Differences’. For more information, click here.