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Consultation: Benzocaine: proposed advisory statements for medicines
This consultation closed on 16 October 2018.
Invitation to comment
The TGA sought comments from interested parties on the addition of a new advisory statement for labels of non-prescription medicines containing benzocaine for topical oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.
The additional RASML advisory statement 'Do not give to children under 2 years of age' is proposed for preparations for topical oral use, except lozenges, due to concerns about the risk of developing methaemoglobinaemia in children under 2 years of age.
(Entry 1 of 4)
|In dermal preparations containing MORE than 2 per cent of total local anaesthetic substances||
(Entry 2 of 4)
|In dermal preparations containing 2 per cent OR LESS of total local anaesthetic substances||
(Entry 3 of 4)
Documents released for consultation on Tuesday, 18 September 2018.
Interested parties to respond by close of business Tuesday, 16 October 2018.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
The TGA is proposing a new advisory statement for labels of OTC medicines containing benzocaine for topical oral use, advising not give to children under 2 years of age due to the risk of methaemoglobinaemia.
With this consultation, the TGA sought comments on the proposed new RASML advisory statement.
Through the consultation process, the TGA requested comments that will help ensure that the proposed advisory statement is appropriate and supports the quality use of the medicine; and that the label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.
The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) sets out the level of control on the availability of medicines in Australia. The majority of medicines that are included in the SUSMP fall under one of the following classifications: Schedule 2 - Pharmacy Medicine (available from a pharmacy without a prescription); Schedule 3 - Pharmacist Only Medicine (available from a pharmacist without a prescription); or Schedule 4 (Prescription Only Medicine). Medicines that are not included in the SUSMP are referred to as 'unscheduled' medicines (freely available from general retail outlets).
Medicines that are unscheduled or included in Schedules 2 or 3 of the SUSMP are collectively referred to either as 'non-prescription medicines', 'over-the-counter medicines' or 'OTC medicines'.
The SUSMP scheduling of benzocaine is currently as follows:
- Dermal preparations containing 2% or less of total local anaesthetic substances
- Lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit
Pharmacy Medicine (SUSMP Schedule 2)
- Topical preparations other than eye drops:
- containing 10% or less of total local anaesthetic substances, except when unscheduled
- in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except when unscheduled
Prescription Only Medicine (SUSMP Schedule 4)
- All other preparations
Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively. However, the enhanced access and availability of OTC medicines means that consumers may not always receive comprehensive advice from a practitioner or pharmacist.
In the context of self-medication, the medicine label is the primary source of information for the consumer; so the label must contain the directions and advisory statements that are needed for safe and effective use of these medicines.
The TGA Labelling Orders require medicine labels to include 'warning statements' where these apply to the medicines, including any advisory statements specified in the instrument made under subsection 3(5A) of the Therapeutic Goods Act 1989 ('the Act'), as in force from time to time.
The Required Advisory Statements for Medicine Labels (RASML)
The RASML is registered on the Federal Register of Legislative Instruments under subsection 3(5A) of the Act, as the Medicines Advisory Statements Specification ('the Specification'). The RASML sets out the advisory statements that are required to be included on the labels of specified medicines.
The current version of the Specification is the Medicines Advisory Statements Specification 2017 (MASS 2017). The MASS 2017 incorporates two versions of the RASML (currently RASML No. 3 and RASML No. 4) as schedules 1 and 2, respectively, to allow for a transition period for adoption of new advisory statements onto medicine labels. RASML No. 3 is the current version. RASML No. 4 will come into effect on 1 January 2019.
The advisory statements required by the RASML are designed to inform consumers about specific risks related to the use of medicines that have been identified during development and evaluation of new medicines, or subsequent pharmacovigilance activities, testing, adverse event reports or from other scientific or clinical information.
The RASML permits the wording of the actual statements that are included on medicine labels to differ from the wording set out in the RASML, as long as the intent is the same.
The RASML currently requires warning statements for benzocaine when formulated in dermal preparations and lozenges (see above table).
Risk of methaemoglobinaemia and proposed additional RASML statement for benzocaine preparations for topical oral use
In May 2018, the United States (US) Food and Drug Administration (FDA) issued a safety alert warning that over-the-counter (OTC) oral products containing benzocaine should not be used to treat infants and children younger than 2 years due to the risk of methaemoglobinaemia. The FDA advised that these products provide little to no benefit for treating oral pain, including sore gums due to infant teething and that benzocaine can cause the life threatening condition methaemoglobinaemia.
Due to this significant safety risk, the FDA has urged manufacturers to stop marketing OTC oral benzocaine products for treating teething in infants and children younger than 2 years. They advised that they will take action to remove these products from the market if companies do not comply. There are no benzocaine-containing products registered in Australia specifically for use in infant teething.
The RASML already specifies the following warning for benzocaine-containing lozenges (in addition to a warning not to take hot food or drink):
"Do not give to children under 6 years of age, unless recommended by a doctor, pharmacist or dentist."
To ensure that health professionals, parents and carers are adequately cautioned against the use of oral benzocaine products in children under the age of 2 years, the TGA proposes that the RASML be updated to include a mandatory warning statement for benzocaine in preparations for topical oral use (except lozenges) as follows:
"Do not give to children under 2 years of age."
Content of submissions
Submissions may address the proposed advisory statements and other identified issues. In addition, submissions might include:
- Whether or not you support the wording of the advisory statement. If you do not support the wording of the statement you may make suggestions for an alternative acceptable to you.
- An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
Enquiries should be directed via email to email@example.com.
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
It is proposed that the advisory statements will be included in the next update to the RASML ('RASML 5'), with an anticipated date of publication on the FRLI in January 2019, and an anticipated date of effect 18 months later (i.e. July 2020) to allow affected sponsors time to update their labels. However, the TGA will expect that all new medicines registered by the TGA from the date of publication of the outcomes of this current consultation will include all the requirements.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- Seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.
- Oral Over-The-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder, US FDA, 23 May 2018