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Many medicines contain excipients derived from known allergens or are produced in facilities where these allergens might be
present. In some drugs, the actives might be allergenic, as in the well-known instance of antibiotics, such as penicillins,
cephalosporines and sulphonamides. Some anticonvulsants and insulin have also been recognized as allergens, and there are
many others that have been implicated as causing or worsening allergies.1However, many consumers are unaware of the potential presence of allergens in medicines, particularly those associated with
excipients, and even consumers that are more aware may struggle to identify the ingredients that pose a risk unless they are
clearly indicated on external packaging.
True allergy represents less than 10% of all adverse drug reactions.1 More common adverse reactions involve toxicity, drug–drug reactions and drug–food reactions. Reactions to aspirin and nonsteroidal
anti-inflammatory agents, such as ibuprofen (Nurofen) and diclofenac (Voltarol) are also frequent causes of allergy-like reactions,
but these are not true allergies as they occur when a drug interferes with the normal mechanisms of the immune system, causing
the direct release of chemical mediators such as histamine.
In the case of true allergy, the greatest concern is that the effects are not dose-dependent and any individual can exhibit
a different sensitivity at different occasions, for example, following exercise. This makes allergens a very special case
because it is impossible to set a maximum exposure level in the same way that one might set a limit for other toxic chemicals.
For sensitive patients, there is no such thing as a safe limit. Food industry experience
The food industries of all major developed countries have been obliged to face up to the allergen risk. Legislation in Europe,2 the US,3 Australia and New Zealand4 dictates a list of allergens that must be specifically labelled if present in a packaged food item. While the requirements
and lists differ between the jurisdictions, the essential point remains that consumers can expect specific allergen advice
on the packaging of food.
However, the labelling of allergens has presented some food companies with difficulties. While the legislation was conceived
with the intention of making life easier for consumers, it is not uncommon to find food items with apparently contradictory
statements; for example, where the ingredient list makes no reference to nuts, and the packaging design and product name are
also suggestive of a nut-free product, the allergen statement advises that the product may contain nuts.
The difficulty arises because there is no acceptable minimum limit that can be set for allergens. Even if the formulation
contains no allergens, any ingredient that is processed in a facility where allergens might be present still constitutes a
risk unless the facility practises strict procedures to avoid cross-contamination.
There is also room for debate as to whether labelling is really necessary with ingredients derived from known allergens. Certain
exemptions already apply so that, whereas a glucosamine sulfate supplement might be labelled as 'containing shellfish', a
beer brewed using isinglass, which is derived from fish, will not be expected to carry a 'contains fish' statement.
However, one positive consequence of the labelling requirement has been a much higher degree of cooperation and monitoring
within the supply chain, particularly for those food manufacturers of 'free-from' products, who must fully understand exactly
how their ingredients are sourced and produced.
A negative consequence is that the legislation has had a major impact on product recalls. In the first 6 months of 2008, 57%
of all food and drink product recalls in the US, and 57% of all those in the UK, were caused by the apparent failure to correctly
label foods that contained allergens.5 One example from the UK is a product, clearly described as a 'whole nut chocolate bar', that was recalled because the label
failed to mention that the product might contain almonds as a specific allergen. In other cases, such as the presence of fish
in a chicken pie, it was not clear whether the fish, or an ingredient derived from fish, had been used in the pie deliberately
or whether there had been contamination.