The European Medicines Agency (EMA) launched a public consultation that discussed the ‘Information for the package leaflet regarding lactose used as an excipient in medicinal products for human use’.
The proposal aims to expand the scope of the current guideline on excipients (which only regulates limit values for the medicines taken orally) with new leaflet provisions for the parenteral and inhaled products, which are common administration routes for patients with allergy to cow’s milk or intolerance to lactose.
Underpinning the principle of transparent, accurate and safe information to patients about medicines, EFA welcomes this EMA initiative. We consider that it fills an information gap for our patient community, and improves their protection against the risk of uninformed intake of lactose.
EFA main points to EMA public consultation on information on lactose
EFA participated in the public consultation by pointing the following aspects:
- Apart from the immediate reactions taken into account in the literature of the consultation, EMA should also consider potential long-term or accumulating adverse health effects of lactose-containing medicine, that in some cases are difficult to detect because of their internal nature and symptoms.
- The current text focuses only on proteins that might be contained in the lactose derived from cow’s milk. EFA proposes to take other milk into account as well, such as bovine milk which also contains lactose and is often linked to lactose intolerance. In this context, it would be helpful to communicate with clarity in order to differentiate between synthetic lactose and lactose from bovine sources.
- With regard to inhalers used as a form to prevent and relieve asthma symptoms, in cases where food allergy and asthma co-exist there is an increased risk of more severe allergic reactions with respiratory symptoms due to hypersensitive airways. Therefore, EFA calls on EMA to consider lactose/milk protein content in dry powder inhalers.
- In some countries, there have been concerns linked with limited support and information available on medication containing lactose. An updated guideline should note that the advice given by doctors or pharmacists will be subject to variance, depending on the clinician’s awareness and understanding of food allergy.
- Given the prevalence of the disease, EMA needs to prioritise allergy as a safety consideration, supported by stronger statements and scientific data. Of course, this should not lead to unnecessary further restrictions for people with allergy/intolerance while protecting health. This can be done with appropriate, transparent and nuanced package information.
- EMA will have to address the issue of different national standards i.e. some Member States do not understand lactose as a problem, as medicinal products normally contain milk that is protein-free and therefore ‘over-labelling’ can lead to unnecessary restrictions. Meanwhile, in others, patients perceive that not mentioning lactose in the package leaflet constitutes a safety issue, as they think that “cheaper” or “generic” medicines may not be produced with such lactose purity.
The full EFA response to the EFSA consultation on complementary feeding in infants is available here.
We thank all our Members from EFA Food Allergy and EFA Allergy and Asthma Working Groups for their input and to put this response together.