Food allergies have become a significant public health concern, affecting both children and adults. Gluten, a protein found in wheat, barley, and rye, can trigger adverse reactions in susceptible individuals, leading to conditions like celiac disease, wheat allergy, and gluten sensitivity. Celiac disease is a prevalent chronic disorder globally, causing nutrient deficiencies and various symptoms. Wheat allergies, especially in children, are common and can mimic celiac disease symptoms. Non-celiac gluten sensitivity is also a recognized condition, impacting individuals differently.
Excipients derived from wheat, oats, rye, and barley, such as starch, are commonly used in pharmaceutical products. Starch, a byproduct of gluten extraction, serves various functions in medications, but corn and potato starch are gluten-free and safe for individuals with gluten-related disorders. Soy, another major allergen, affects about 1.5% of the European population and is a common childhood food allergy. Soy allergy symptoms can range from mild to severe, affecting different body systems.
Soy, with its unique proteins and properties, is a common ingredient in various pharmaceutical formulations, including inhalers, tablets, suppositories, and cosmetics. While there is no cure for gluten or soy allergies, complete avoidance of these allergens, even in medications, is crucial for managing allergic reactions. Recent studies indicate the prevalence of celiac disease and soy allergies globally, emphasizing the need for clear labeling and heightened awareness among healthcare providers and patients.
A study in Portugal assessed the presence of gluten and soy-derived excipients in 308 medicinal products, focusing on analgesics, antipyretics, NSAIDs, and antiasthmatics. The research revealed significant associations between pharmacotherapeutic groups and the presence of these allergens, with varying prevalence across different drug classes and dosage forms. Gluten was more common in analgesics and antipyretics, while soy-derived excipients were prevalent in NSAIDs.
Analysis of dosage forms showed that solid oral formulations of analgesics and antipyretics had a higher prevalence of gluten, especially in film-coated and regular tablets. Liquid oral forms of NSAIDs contained more gluten, indicating potential risks for individuals with gluten sensitivities. Similarly, soy was found in liquid oral formulations of analgesics and antipyretics and solid oral forms of NSAIDs, posing risks to soy-sensitive individuals.
Manufacturers must improve allergen labeling on medicinal products to ensure patient safety, especially for sensitive populations with gluten and soy allergies. Transparency in disclosing excipient origins and potential allergens is essential to help patients make informed choices and avoid allergic reactions. Regulatory frameworks should address gaps in allergen reporting and promote standardized labeling practices to enhance patient care and safety.
This study sheds light on the prevalence of gluten and soy in medicinal products and underscores the importance of clearer labeling to protect individuals with food allergies. Enhanced awareness among healthcare providers and patients is crucial to mitigate allergic reactions and promote safer medication use for those with gluten and soy sensitivities.
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