Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 1997; 2: 185
The German Federal Drug Administration issued new criteria in drug safety. MAHs generally must warn to use their medicament during pregnancy unless it is proven that there are no fatal effects. Aim of this retrospective study is to evaluate the outcome of 1000 pregnancies during which Sinupret was prescribed.
Although there is evidence from reproductive toxicology that Sinupret has no fatal effects during pregnancy, the design of a retrospective study was undertaken for ethical reasons. The CRF were handed out to GPs and gynaecologists, who prescribed Sinupret either because of sinusitis or bronchitis. Documentation contains a combination of the “Mutterpaß” and a query with documentation of special risk factors for malformation, medicament intake during pregnancy, and adverse effects of the medicaments taken.
A first overview of the CRFs showed malformation rates far below historical data, which report on malformation rates of 7.5% in active systems, rates between 1.5–3% in passive systems and the official rate of 0.3% of the Federal Office of Statistics, Germany.
We do not believe that the lower malformation rate is an effect of Sinupret. Possible bias on the outcome might be e.g. a preformed opinion of the prescribers or a non-representative probe of pregnant women, which may have been admitted to hospital as soon as there was evidence of malformation.
