I received an answer to my communication yesterday.... Thank you...

I received an answer to my communication yesterday....

Thank you for your enquiry.

Astodrimer sodium was first included in Schedule 3 of the Poisons Standard in February 2019. In the published interim decision, which was later confirmed in the final decision, the TGA decision maker (Delegate) outlined the reasons for the decision, including the following:

“The risks associated with astodrimer remaining unscheduled include the potential for self-treatment without health professional involvement to exclude sexually transmitted infections (STIs). Although the consumer can identify the symptoms that may be treated by the medicine, counselling and verification by a pharmacist is required before use. In addition, with astodrimer in Schedule 3 and pharmacist involvement in their care, women are more likely to seek further advice from a doctor should over-the-counter (OTC) treatment be ineffective.”

The Delegate recognised the minimal adverse effects associated with use of the substance, but was of the view that this factor was outweighed by the identified risks of the substance remaining unscheduled.

Please note anyone can make an application to amend the Poisons Standard, and there is no fee charged for doing so. The application form and information on how to lodge an application, with supporting evidence, can be found on the TGA website at: https://www.tga.gov.au/form/application-amend-poisons-standard.

Kind regards

Dion

The Chemicals and Medicines Scheduling Secretariat Team

So now we know why TGA, of all regulators around the world, chose to take this action. The delegate, who made the decision, while recognising the "minimal adverse effect associated with use of the substance" thought the risk of a woman treating herself for unidentified sexually transmitted infections (STIs) was too great. There is no further clarification of this opinion (for that is what it is). There was no elaboration or clarification of this opinion.

I suggest the delegate is a medical practitioner with an interest in keeping his or her waiting room full.

What we do know is that metronidazole (flagyl) is effective as a treatment for BV and STI's so perhaps this is where he or she was coming from. But there is a very real risk from the development of antibiotic resistant disease and from the known side effects of antibiotic treatment.

I would welcome the views of medical practitioners on this forum.