Hilfsstoffe in Arzneimitteln – keine inerten Substanzen
Elke Röhrdanz und Klaus Olejniczak
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn
Corresponding author: PD Dr. Elke Röhrdanz, Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn (Germany); e-mail: firstname.lastname@example.org
Pharmaceutical Excipients – No “Inert” Substances
Although most adverse reactions are due to the drug itself, a small but not unimportant part can be attributed to excipients. Such adverse reactions may be caused by impurities present in the excipient, by unexpected interactions between drug and excipient or by the excipient itself. Excipients may furthermore pose a risk only for specific populations like newborns and children. This publication will give some examples. Thanks to the current rigid regulations applied for drug approval, cases similar to the ones reported have become a thing of the past. Generally, possible adverse reactions of excipients are known at drug approval and a respective labelling is requested for the product information. Counterfeit medicines represent the biggest current hazard since they are increasingly distributed via the internet and are therefore hard to control.
pharmind 2009, Nr. 4, Seite 661