Table 7.
Adverse effects in special populations.11
| 1st generation | 2nd generation | |
|---|---|---|
| Renal/liver failure | Few studies. It may be potentially associated with adverse effects. | Data evaluated for each drug. The drug package leaflet should be consulted for possible dose changes. |
| Elderly | Impairs cognition, memory and attention. It can lead to falls, delirium, and incontinence. | Data evaluated for each drug. The drug package leaflet should be consulted for more information. |
| Pregnant women | Diphenhydramine and chlorpheniramine are classified as Class Ba drugs (FDA). Irritability and drowsiness have been reported in infants. | Cetirizine and loratadine are classified as Class Ba drugs (FDA). Desloratadine, fexofenadine and levocetirizine are Class Ca drugs (FDA). No adverse effects have been reported in infants. |
| Neonates | May cause irritability, drowsiness and respiratory depression. | No effect on central nervous system. |
| Children | Potential risk of adverse effects. | Long-term safety for cetirizine, desloratadine, fexofenadine, levocetirizine and loratadine has been demonstrated. |
Adapted from Simons and Simons.2
Risk classification of drug use in pregnancy, according to the Food and Drug Administration (FDA). Category A – adequate and well-controlled studies have not shown any risk to the fetus in the first trimester of pregnancy (there is no evidence of risk in other trimesters); B – studies on animal reproduction have not shown a risk to the fetus and there are no adequate and well-controlled studies in pregnant women; C – animal reproduction studies have demonstrated adverse effects on the fetus and there are no adequate and well-controlled studies in humans; however, the potential benefits may justify the drug use in pregnant women despite the potential risks; D – there is evidence of risk to the fetus based on adverse reactions from investigational studies or post-marketing studies; however, the potential benefits may justify the drug use in pregnant women despite the potential risks; X – animal or human studies have demonstrated fetal alterations or evidence of risk to the human fetus based on adverse reactions from investigational or post-marketing studies and the risks involved in the drug use in pregnant women do not justify the potential benefits. FDA Pregnancy Categories. Available at: http://www.drugs.com/pregnancy-categories.html [accessed 02.04.16].