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21 June 2018

RASML Officer Office of Scientific Evaluation Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 [email protected]

Submitted via upload facility

Dear Sir / Madam,

Consultation: Proposed additional advisory statements for – Sedating oral : (trimeprazine), , , , , , , , .

ASMI (Australian Self Medication Industry) is the peak body representing companies involved in the manufacture and distribution of consumer health care products (non-prescription medicines) in Australia. ASMI also represents related businesses providing support services to manufacturers, including advertising, public relations, legal, statistical and regulatory consultants. Further information about ASMI and ASMI members is available on our website (www.asmi.com.au).

ASMI values this opportunity to provide comment on the proposed warning statements for oral sedating antihistamines.

In this response, we will address each of the five separate entries and provide comments. In our response we refer to the five different entries, but for brevity we will not reproduce the tables in the TGA consultation.

ASMI Comments:

Proposed changes – Sedating Antihistamines Entry 1 of 5

ASMI supports the TGA’s proposed RASML statements for entry 1 of 5.

ASMI agrees with the proposal to list the substances to which the entry refers (Column 1), as well as the changes to Column 2 conditions.

The Column 3 required statements are clear and appropriate for this entry.

Proposed changes – Sedating Antihistamines Entry 2 of 5

ASMI supports the TGA’s proposed RASML statements for entry 2 of 5.

Advancing consumer health through responsible self care

As per the Entry 1 of 5, we support the listing of the different substances in Column 1 and the description of the conditions in Column 2.

The Column 3 required statement is an appropriate statement for products that are labelled for use in children.

Proposed changes – Sedating Antihistamines Entry 3 of 5

For the reasons already described above, ASMI supports the proposed changes for Entry 3 of 5.

Proposed changes – Sedating Antihistamines Entry 4 of 5

For the reasons already described above, ASMI supports the proposed changes for Entry 4 of 5.

Proposed changes – Sedating Antihistamines Entry 5 of 5

ASMI supports the proposed statements “This product should be taken on medical or pharmacist advice” and Do not give to children under ‘x’ years of age” and also supports the Column 2 conditions.

ASMI also requests that the TGA considers some additional changes to Entry 5 of 5, for the reasons described below. We acknowledge that these changes are not entirely within the scope of this consultation however the issues that we raise have been brought to our attention by way of this consultation, so we believe that this may be an opportunity for the TGA to address this matter.

The changes that we wish to propose relate to the existing statement “Not recommended for use by pregnant or breastfeeding women”.

We draw the TGA’s attention to the use of doxylamine by specialist obstetricians and gynaecologists to treat severe and vomiting in pregnancy1,2. Diphenhydramine may also be used for this purpose, for persistent nausea and vomiting in or hyperemesis. It is available on some hospital formularies for this purpose.

Both doxylamine and diphenhydramine are Category A in pregnancy, as per the TGA Prescribing Medicines in Pregnancy Database3.

We acknowledge that use for this indication is off-label and not appropriate for use without medical advice. The sponsors of single ingredient doxylamine and diphenhydramine do not market the OTC products for severe nausea & vomiting in pregnancy, nor do they promote or supply the products for this indication. Responsibility for use for this purpose in pregnant women rests solely with the prescribing medical practitioner. We do not advocate that RASML entries should refer to this indication.

We are also aware that confusion sometimes occurs when specialists or GPs advise pregnant women to take doxylamine or diphenhydramine for severe nausea & vomiting in pregnancy, advising them that it is an OTC , which they then purchase from the pharmacy. Women (justifiably) are then concerned and confused with the RASML statement “Not recommended for use by pregnant or breastfeeding women” or “Do not use if you are pregnant or breastfeeding”.

To avoid confusion while still maintaining appropriate and strong warning statements for consumers, ASMI also suggests the following changes:

1 https://www.racgp.org.au/afp/2016/august/managing-nausea-and-vomiting-in-pregnancy-in-a-primary-care- setting/ 2 https://www.nps.org.au/australian-prescriber/articles/treatment-of-nausea-and-vomiting-in-pregnancy 3 https://www.tga.gov.au/prescribing-medicines-pregnancy-database Page 2 of 4

• Entry 5 of 5 could be amended so that it is specifically for promethazine (i.e. Column 1 to refer to promethazine). Column 2 and 3 conditions should remain the same as proposed. • The current warning statement "Not recommended for use by pregnant or breastfeeding women" should be retained for promethazine, which is Category C, as should the additional drowsiness statements, i.e. Column 3 should be retained as per proposed wording of warning statements. • A separate 6th entry could be created specifically for doxylamine and diphenhydramine in Column 1; these are both A medicines • This 6th entry should have the same Column 2 conditions, "In oral medicines indicated for short term use in : which include dosage instructions for adults and children, aged from 'x' years, where 'x' must not be less than 2. Women are advised about these indications by their doctor when the product is prescribed. • This 6th entry could include amended pregnancy and breastfeeding warning statements: o "Do not use if you are breastfeeding" o "Do not use in pregnancy except on medical advice" • For this 6th entry, the other proposed and existing warning statements should be retained, as per those for promethazine. • Separation of the entries w ill allow for more nuanced RASM L entries that do not confuse women and pharmacists in the event of off-label prescribing of these medicines ...... , ... "'...... e111 ,Ill LI•e1a1e •••-... l~,f'- I 1•1 - I • 11:..1 - Antihistamines (Entry 5 of 6) In oral medicines indicated for This product should be taken on SHORT TERM USE IN INSOMNIA: medical or pharmacist advice. Promethazine Do not give to children under 'x' which include dosage years of age. instructions for adults and Not recommended for use by children aged from 'x' years pregnant or breastfeeding (w here 'x' must not be less than women. 2) Do not take this medicine for more than a few days. This preparation is to aid . Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid .

Antihistamines (Entry 6 of 6) In oral medicines indicated for This product should be taken on SHORT TERM USE IN INSOMNIA: medical or pharmacist advice. Doxylamine Do not give to children under 'x' Diphenhydramine which include dosage years of age. instructions for adults and children aged from 'x' years Do not use of you are (where 'x' must not be less than breastfeeding 2) Do not use in pregnancy except on medical advice

Do not take this medicine for more than a few days. This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.

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ASMI believes that the doxylamine and diphenhydramine entries could be differently worded so that they do not directly conflict with the Category A pregnancy categorisation, and so that women who are prescribed these products on the advice of an obstetrician / GP can understand that the product can be used if a doctor prescribes it.

ASMI appreciate that use of this product in pregnancy should only occur on specialist recommendation and the intent of the amendments that we have proposed is to mitigate confusion among pregnant women.

ASMI supports all other changes to RASML sedating entries.

We trust that this information has been useful and constructive. Please contact me should you require any further information.

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