Australian TGA Announces Further Public Consultation on Access to Alkyl Nitrites

By on November 26, 2018

Sydney, NSW -Prior to making a final decision on possible amendments to the Poisons Standard schedule for alkyl nitrites, the TGA decision-maker (delegate) has requested that further public consultation be undertaken. There will not be a decision announced on alkyl nitrites on 29 November 2018.

The reasons for considering amendments to the Poisons Standard for alkyl nitrites, the main component of “poppers”, arise from the need to balance several factors:

The products have significant use among a number of groups in the Australian community.

Because many products contain prescription-only substances, such access may not be legal.

While many people apparently use inhaled alkyl nitrite products without adverse effect, some serious health impacts have been reported in certain users from both inhalation and ingestion of alkyl nitrite containing products. These include loss of vision (maculopathies or retinal damage) and presentation in hospital emergency departments and subsequent hospitalisation due to methaemoglobinaemia. Methaemoglobinaemia is a very serious condition which results in less oxygen delivery to bodily organs resulting in chest pain, shortness of breath, altered mental state and possible permanent organ damage. More commonly, the alkyl nitrites can cause low blood pressure, tachycardia, dizziness, nausea and fainting, especially if the user is taking certain prescription medicines.

There is some, incomplete evidence that particular members of the family of alkyl nitrite substances may be more toxic than others.

In order to assess the possible impact of different approaches to access and safety controls on risks associated with alkyl nitrites, a discussion paper outlining these factors will be published on the TGA website on Thursday 29 November 2018. This will include discussion of a range of possible options on access controls. These range from general (unrestricted) sale, through to access in pharmacies, pharmacist only access, prescription only access or prohibited substance status, and whether it is appropriate to apply different access controls to different members of the alkyl nitrite family of substances.

Interested individuals and organisations will be invited to provide submissions in writing by 15 January 2019. The TGA also proposes to hold public meetings in Sydney and Melbourne at the end of January or early February 2019. Details on how to register your interest in these meetings will also be provided on 29 November 2018.

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