Withdrawal from the market
Rhinathiol Promethazine (Sanofi-Aventis Suisse SA, category C) contained a combination of the sedative antihistamine promethazine and the expectorant mucolytic carbocisteine. According to the package insert, the syrup could be taken for both productive cough and irritable cough (1). It was frequently used in children. The drug was withdrawn from the market on January 31, 2009. According to official information from Sanofi-Aventis, this was agreed with Swissmedic because the combination of a mucolytic with an antitussive is no longer considered relevant and does not meet modern medical recommendations (2). Blockade of the cough reflex in a productive cough can lead to airway secretion congestion, bronchospasm, and respiratory infections.
Comment
With Rhinathiol Promethazine, the last promethazine preparation also disappeared from the Swiss market. Promethazine is not exclusively an anticholinergic antihistamine, but chemically and pharmacologically also a psychopharmaceutical from the group of phenothiazines. It has marked sedative and weak antipsychotic properties (3). The use of promethazine in children is not without risk. The literature contains reports of very rare serious adverse effects. The FDA prohibits its use in children younger than 2 years of age because of the potential risk for severe respiratory depression and advises caution in its use in children older than 2 years (4). We suspect that the popularity of the drug was due primarily to its sedative and sleep-inducing effects. The children were anesthetized, as it were, and were able to sleep at night despite a tormenting cough (and so were the parents). Opium was administered to children in the past for a similar purpose (5).
Alternatives
A similar combination of an antihistamine with a mucolytic continues to be found, for example, in Solmucalm (chlorphenamine + acetylcysteine). Here too, of course, the question arises as to whether such a combination is useful. Oxomemazine (Toplexil N) is a sedating antihistamine and has similar effects to promethazine. It should be used with caution and may be dispensed in pharmacies to children and adolescents 18 years of age and younger only with a physician’s prescription (6). Rhinathiol, the monopreparation containing the expectorant carbocisteine, remains on the market. In addition, numerous other antitussives and expectorants for cough are on the market. The efficacy of most synthetic cough suppressants has not been reliably proven scientifically. At the same time, however, in very rare cases, these can cause serious adverse effects in children. Therefore, we believe that children should usually be given well-tolerated herbal or alternative medicine remedies rather than the chemical ones.
