The identification and validation of signals in pediatric practice is very time consuming. The presence of certain problems, such as a shortage of drugs approved for use in pediatrics, a low percentage of reporting of AD messages in children and poor quality of filling in messages, increases the significance of the identified signal. Full-service pharmacovigilance organizations that produce the master file and other pharmacovigilance documents help ensure that country-specific standard operating procedures (SOPs) demonstrate good pharmacovigilance practice.

In screening aimed at detecting the signal in the child population, an association was noted between the intake of desloratadine and the increase in body weight. Since desloratadine is an active metabolite of loratadine, reports were taken into account not only for desloratadine, but also for loratadine. In the instructions for the medical use of a number of loratadine drugs registered in the State Register of Medicines Approved for Medical Use in the Russian Federation, it is indicated that loratadine is a selective blocker of peripheral H1-histamine receptors. It has antiallergic, antipruritic, anti-edema effect. Loratadine does not penetrate the blood-brain barrier, does not affect the central nervous system, does not have anticholinergic and sedative effects, does not cause addiction, is compatible with food. Loratadine does not bind to H2-histamine receptors and practically does not affect the function of the cardiovascular system and heart rate. Desloratadine is the main active metabolite of loratadine.

Loratadine and desloratadine are approved for use in adults and children from a certain age (from 2 to 12 years old, depending on the dosage form of the drug and the content of the active substance), are dispensed in pharmacies without a prescription. Organizations providing a full range of pharmacovigilance services, generating a master file and other documents on pharmacovigilance, revealed the following: from spontaneous drug safety reports received in 2016 in the WHO global VigiBase database from 22 countries, 115 weight when taking loratadine and 44 reports when taking desloratadine. In 97 of 115 reports of weight gain and increased appetite reported to VigiBase, loratadine was the only drug suspected. Of these, 11 were for children between the ages of 2 and 11. Loratadin was the only drug suspect in 9 out of 11 reports. The time to the onset of HP development varies from 1 day to 7 months. In two cases (3 and 4), other suspected drugs were reported, of which only one could cause weight gain. A case is described in a ten-year-old boy who gained 4 kg in weight during a month of treatment with loratadine. Standard operating procedures (SOPs) of pharmacovigilance, the formation of a master file in the framework of good pharmacovigilance practice allowed to show that after discontinuation of the drug, the boy returned to his original body weight. The patient also experienced a reversible weight gain upon repeated administration. Attention is drawn to an increase in weight up to 30 kg in a 4-year-old child (in accordance with international standards presented by WHO, the weight norm for girls 4 years old is from 14.2 to 18.8 kg), who was treated with loratadine for 2.5 years … Among 44 reports of weight gain and increased appetite with the use of desloratadine, identified in 2016 in VigiBase, in 34 cases, desloratadine was the only suspect drug. Of these, 11 cases of such HP were observed in children of the age group from 2 to 11 years. Desloratadine was the only drug suspect in 5 out of 11 cases. The time to the onset of HP development varies from 1 day to 20 months.

A case of the use of desloratadine by a 7-year-old boy is described, who had a significant increase in appetite from the first day of treatment. As a result, the child gained 4.5 kg in weight during two months of treatment with desloratadine. After discontinuation of the drug, appetite returned to normal and weight began to decrease. Standard operating procedures (SOPs) for pharmacovigilance within the framework of good pharmacovigilance practice allowed for the inclusion of preventive measures. Re-administration of the drug again led to an increase in appetite, but the patient’s weight was controlled by diet. In another case, edema could have been the cause of weight gain; HP was recorded 6 days after the end of the drug intake. In 4 out of 11 cases, children simultaneously took montelukast, in the instructions for the use of which the increase in weight and appetite is also not described.

* G. V. Kutekhova, E. O. Zhuravleva, M. A. Darmostukova, I. I. Snegireva, Yu. Welts, R. N. Alyautdin, E. V. Shubnikova

* G. V. Kute