This month, Coeliac New Zealand wants to highlight an important but often overlooked area for people living gluten free: medications.

We have recently been made aware of a brand change for dexamfetamine (a medication used for attention-deficit hyperactivity disorder (ADHD)). The brand has transitioned from Noumed to Aspen Pharmaceuticals, and the new Aspen formulation contains gluten. This change serves as an important reminder that we must regularly check our medications, as brand switches can happen without warning.

While we are experts at scanning food labels, medication can be easily missed in the sea of information provided at diagnosis. Checking your prescriptions is another task in our busy lives, but with a few tips and tricks, you can navigate this topic with confidence.

Why do some medications contain gluten?

Tablets and capsules consist of active ingredients (the medicine itself) and inactive ingredients, known as excipients. Excipients help bind, coat, or stabilise the medicine.

While many manufacturers use corn-derived starch, some use wheat starch. For those with coeliac disease, this poses a significant health risk.

Legislation and Labelling in New Zealand

The Medicines Act 1981 regulates products to ensure they are safe and effective. Historically, labels only required the medicine's name, active ingredients, batch number, and expiry date.

However, as of March 2024, new labelling requirements mandate that excipients, including gluten, must be disclosed. If a medication contains more than 3ppm, it must include a warning statement on the box, packaging, or information leaflet. This makes it much easier for consumers to identify allergens at a glance.

Note: If you find a medication that you believe does not meet these standards or fails to state an appropriate gluten warning, you can file a complaint with Medsafe, New Zealand’s medicines safety authority. You can Report a Problem here.

Tips for Navigating Your Medications

To ensure your medicine is safe, keep these steps in mind:

• Talk to your Pharmacist: When picking up a prescription, ask if the medication is gluten free or if the brand has changed. Pharmacists have access to detailed datasheets and can contact the drug company directly.
• Check Under the Label: Pharmacists sometimes stick the prescription instructions directly over the ingredients list.
• Read the CMI: Check the Consumer Medication Information (CMI) leaflet inside the box. If it’s missing, you can search for your specific brand on the  Data Sheets and Consumer Medicine Information.
• Monitor Pharmac Notices: Stay informed about supply issues and brand changes by checking the Pharmac website.
• Report: If a label seems incorrect or lacks a required warning, report it to Medsafe to help protect the wider community via Report a Problem.

Checking your medication should become as second nature as checking food products while grocery shopping. Staying vigilant, asking questions and working closely with your healthcare team, you can continue thriving gluten free.

References:

Healthify He Puna Waiora. (2024, May 1). Excipients in medicines. https://healthify.nz/medicines-a-z/e/excipients-in-medicines

Healthify He Puna Waiora. (2024, June 14). Gluten in medicines. https://healthify.nz/medicines-a-z/g/gluten-in-medicines

Medsafe. (n.d.). Labelling of medicines and related products. New Zealand Medicines and Medical Devices Safety Authority. https://www.medsafe.govt.nz/regulatory/labelling.asp#form

Medsafe. (2023). Excipients: New labelling requirements [Fact sheet]. New Zealand Medicines and Medical Devices Safety Authority. https://www.medsafe.govt.nz/consumers/educational-material/Excipients-New-labelling-requirements.pdf

Medsafe. (2024). Guideline on the regulation of therapeutic products in New Zealand. Part 5: Labelling of medicines and related products (Edition 4.0). New Zealand Medicines and Medical Devices Safety Authority. https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part5.pdf

NZ Formulary. (2022, November). Gluten and lactose in medicines. New Zealand Medicines Information Service (NZMIS). https://medicinesinformation.co.nz/bulletins/gluten-and-lactose-in-medicines/

Article provided by Georgia Blomquist Coeliac New Zealand Health Promotion and Education Manager