Moritz K, Rascher W, Toni I, Zahn J, Neubert A (2020)
Publication Type: Journal article, Review article
Publication year: 2020
DOI: 10.1007/s00112-019-00828-4
First generation H1 antihistamines (e.g. dimenhydrinate, diphenhydramine and doxylamine) have been an essential component in pediatric drug treatment for many years. In recent years there have been an increasing number of reports of serious (including fatalities) side effects in infants following the use of these drugs. For this reason, in 2017 the Federal Institute for Drugs and Medical Devices (BfArM) initiated a risk assessment procedure and reassessed the benefit-risk ratio based on the available data. As a result the oral and rectal use of antiemetics containing dimenhydrinate and diphenhydramine in children below 3 years of age suffering from nausea and vomiting associated with simple gastroenteritis and feverish infections are no longer indicated. In addition, doxylamine became a prescription-only drug. This article illustrates the background to why and how the use of first generation H1 antihistamines is now restricted and the effects which the reporting of adverse drug reactions can have.
APA:
Moritz, K., Rascher, W., Toni, I., Zahn, J., & Neubert, A. (2020). Zulassungseinschränkung der Antihistaminika der ersten Generation für Kinder unter 3 Jahren aufgrund eines negativen Nutzen-Risiko-Verhältnisses. Monatsschrift Kinderheilkunde. https://dx.doi.org/10.1007/s00112-019-00828-4
MLA:
Moritz, Katrin, et al. "Zulassungseinschränkung der Antihistaminika der ersten Generation für Kinder unter 3 Jahren aufgrund eines negativen Nutzen-Risiko-Verhältnisses." Monatsschrift Kinderheilkunde (2020).
BibTeX: Download