A recent study published in Scientific Reports examined the presence of gluten- and soy-derived excipients in medicinal products authorized for sale in Portugal. The study highlights the risks posed to individuals with food allergies, particularly those with gluten and soy sensitivities, due to the use of these ingredients in common medications.
Food allergies, especially those to gluten and soy, are a growing public health concern. Gluten is a protein found in barley, rye, and wheat, and it can trigger adverse reactions in individuals with gluten sensitivity, including conditions like celiac disease (CD), wheat allergy, and non-celiac gluten sensitivity. Similarly, soy is one of the top food allergens, often causing reactions ranging from mild symptoms like hives to more severe responses such as anaphylaxis.
Study Overview
The study investigated the prevalence of soy- and gluten-derived excipients—substances added to medications as inactive ingredients—in therapeutic products prescribed in Portugal. The team focused on popular medicinal categories, including non-steroidal anti-inflammatory drugs (NSAIDs), antipyretics (fever-reducing drugs), and anti-asthmatics (bronchodilators). Paracetamol (acetaminophen) and ibuprofen, both of which are frequently used in Portugal, were chosen for the study because of their widespread use and public health relevance.
A total of 308 medicinal products were analyzed, encompassing 108 antipyretics, 115 bronchodilators, and 85 NSAIDs. The researchers looked for gluten and soy-derived excipients such as starches (a major source of gluten), soy lecithin, and xanthan gum.
Key Findings
Gluten in Medications:
Gluten-containing excipients were predominantly found in film-coated tablets, with over 60% of gluten-containing antipyretics in this form. In particular, the study found that 51.2% of solid oral paracetamol-based medications and 40% of liquid oral forms of the same class contained gluten.
Wheat-derived starches, often listed simply as “starch” on labels, were a major source of gluten. This lack of specification makes it difficult for consumers to identify whether the starch is derived from a gluten-containing source like wheat or from a gluten-free source like corn or potato.
Soy in Medications:
Soy-derived excipients were more prevalent in NSAIDs and antipyretics, with 30% of liquid oral formulations and 33.3% of rectal suppositories containing soy. Xanthan gum, commonly used as a thickener in liquid medications, was often derived from soy and was found in 60% of liquid antipyretics.
The study also noted that branded medications were more likely to contain soy-derived excipients compared to generic versions.
Inhalers as Allergy-Safe Alternatives:
In contrast to oral medications, none of the 115 anti-asthmatic and bronchodilator inhalers analyzed contained any soy- or gluten-derived excipients. This suggests that inhalers, with their simpler formulations, may offer safer alternatives for individuals with these allergies.
Implications for Public Health
The study’s findings have important safety implications for individuals with gluten sensitivity, celiac disease, or soy allergies. For instance:
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Individuals with celiac disease or non-celiac gluten sensitivity should exercise caution when using solid oral antipyretics and analgesics, as these medications may contain gluten.
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Those with soy allergies should be particularly cautious when using liquid oral medications and rectal suppositories, where soy-derived excipients are more commonly found.
The research also underscores the need for better labeling practices in the pharmaceutical industry. While the Summary of Product Characteristics (SmPC) database was used for this study, the lack of clear information on the botanical origin of starches leaves consumers guessing about potential gluten risks. Furthermore, cross-contamination during manufacturing could also pose risks, as the presence of soy or gluten may not be disclosed by manufacturers.
Conclusions
The study calls for greater transparency in labeling and more comprehensive allergen information on medicinal products. Clearer labeling would help individuals with allergies make informed decisions and avoid unintentional exposure to allergens. The researchers also recommend that pharmaceutical manufacturers explore alternative formulations that minimize or eliminate soy and gluten-derived excipients to ensure safer medication use for allergic individuals.
Given the risks identified in this study, healthcare providers are encouraged to be vigilant and inform patients about potential allergen risks in the medications they prescribe. With proper labeling and awareness, the safety of individuals with gluten and soy sensitivities can be better protected.
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