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CONTRAINDICATIONS AND PRECAUTIONS

CONTRAINDICATIONS AND PRECAUTIONS

Consumers and patients who know they are hypersensitive (allergic) to one of the ingredients in the Sinupret products should exercise caution before using Sinupret (see Chemistry section above).31 Due to lack of clinical data on children, Sinupret Plus/Sinupret Adult Strength and Sinupret Forte Sugar Coated tablets should not be used by children younger than 12 years old.1 Children younger than 12 years old can use the liquid form, Sinupret Syrup for Kids, according to the manufacturer’s information.1

Pregnancy and Lactation

Sinupret use during pregnancy and lactation has not been fully studied and should be used only after careful risk-benefit evaluation by a patient’s physician or other appropriate healthcare provider.31

The safety of Sinupret during pregnancy was evaluated in a retrospective surveillance study conducted from 1992-1997.32 Data was collected from 762 pregnant women who were treated with Sinupret Sugar Coated tablets or drops, as desired, for at least 24 hours during pregnancy. The patients were from 150 study centers in Germany. The data was compared to the data in the prospective population-based Mainz congenital birth registry for congenital malformations. This birth registry includes 94.8% of all births in Rheinhessen, Germany. The pregnant women in the study were treated with Sinupret Sugar Coated tablets or drops for sinusitis (59.4%), bronchitis (20.2%), or both (20.2%). The mean duration of treatment for sinusitis was 10.4 days, for bronchitis 11.8 days, and for the combination 11.9 days.

The study population and Mainz population were similar in mean age, percent of first and second pregnancies, and duration of pregnancy.32 The study population had significantly (p values not reported) more patients with obesity (BMI > 30), multiple pregnancies (twins), premature labor, and nicotine abuse. From the 762 pregnancies, there were 782 live births, 3 miscarriages, and 1 still birth.32 Compared with the Mainz birth registry and the standard references for West-European infants, there were no differences in birth weight, body length, or head circumference. In the study population there were 5 congenital malformations: Talipes equinovarus (clubfoot), renal duplication, cleft lip, single umbilical artery, and aplasia of corpus-callosum (absence of the corpus-callosum of the brain plus laryngo-tracheomalacia—cartilage in airway too soft and collapses during breathing). There were also 1 chromosome aberration (Trisomy 21) and 3 deformities: 2 cases of talipes calcaneus (weakness or absence of calf muscle so toes point up and person walks on heels) and 1 case of talipes adductus (inversion of foot with only the outer side of sole touching the ground).

In 8 of the 9 newborns with birth defects, a causal relationship with Sinupret was completely ruled out.32 In the case of single umbilical artery, it was determined that Sinupret could have theoretically caused the adverse event (AE) but not likely because Sinupret was taken at the 21st week of gestation and single umbilical artery deformity rarely occurs late in pregnancy.32,33 Also the patient had other risk factors for birth defects. One case of miscarriage was ruled to be theoretically possibly caused by Sinupret because the miscarriage occurred shortly after ingestion of Sinupret.32 However, the patient also had other risk factors that could have contributed to the miscarriage. The birth defect incidence rate in this study was 1.1%. This is lower than expected considering that the prevalence of malformation is 2-3% in passive registries and 6-7% in active registries.34,35 The authors concluded that a reasonable correlation between the intake of Sinupret and teratogenic or embryotoxic effects was not proven.32