Background and Importance Recently, the International Agency for Research on Cancer (IARC) has classified aspartame as possibly carcinogenic to humans. Furthermore, the Joint Expert Committee on Food Additives (JECFA) administered by the Food and Agriculture Organization of the United Nations in partnership with the World Health Organization has accepted a daily intake of 40 mg/kg body weight as safety threshold.

Aim and Objectives The primary objective was to compare the maximum daily intake of aspartame (MDIa) for every oral medicine marketed in our country with the safety threshold established by the JECFA. MDIa was defined as the daily amount of aspartame taken if using the maximum dose of the corresponding drug according to its label dosage recommendations.

Secondary objectives included describing the main features of these medicines and analysing their association with MDIa.

Material and Methods Bibliographic unicentric study carried out in a tertiary hospital.

Collected variables included medicine name, dosage form, authorised indication and milligrams of aspartame per unit in solid forms or per millilitre in liquid forms. Data were expressed as amount (percentage) for qualitative variables and median (interquartile range) for quantitative variables. Difference of medians was assessed through Mann-Whitney U test.

Results 370 medicines declared containing aspartame. According to their respective authorised indications, 222 (60.0%) were considered medication for chronic use and 148 (40.0%) acute care drugs. Regarding dosage form, 283 (76.5%) were fast disintegrating tablets, 68 (18.4%) oral solutions/suspensions or powders for oral solution/suspension and 19 (5.1%) other.

Median dose of aspartame was 3.0 mg/unit (1.3–8.0) for solid forms, and 12.5 mg/mL (5.0–30.0) for liquid forms. For the total population of study, MDIa was 9.0 mg per unit or mL (3.0–20.8) and the absolute largest observation was 420.0 mg/mL. Specifically, median MDIa for solid forms was 8.0 mg/unit (2.1–11.2) and for liquid forms was 75.0 mg/mL (30.0–90.0); the difference between these medians was statistically significant (p<0.001).

Conclusion and Relevance All medicines marketed in our country containing aspartame remain under the threshold established by the JECFA for most adult population. However, since liquid forms contain considerable amounts, their suitability as chronic treatments should be reconsidered for children or other very-low weight patients during medication review, especially if polymedicated.

These results should be comparable to the rest of European countries.

Conflict of Interest No conflict of interest.