Response to Letters by Clapp and Williams and by Michaels

Abstract

This chapter reviews drugs that affect autonomic functions or the extrapyramidal system. In a double-blind, randomized, placebo-controlled, crossover study, 13 healthy volunteers took TrimSpa, which contains more than 30 ingredients, including Ephedra 15 mg and caffeine 60 mg, or matching placebo tds for 7 days with a 7-day washout period between treatments. There were no differences in QTc interval or systolic blood pressure between the two groups. It was found that there was no evidence of teratogenic effects of oral decongestants (mostly that contained phenylpropanolamine) in 2,474 Swedish women who had reported the use of oral decongestants during early pregnancy and 1,771 women who used oral prescription decongestants later in pregnancy. Paradoxically, use of decongestants showed favorable neonatal outcomes such as a reduced risk of preterm birth, low birth weight, small-for-date infants, and perinatal deaths. The findings of this study differ from previous reports of congenital malformations, notably gastroschisis and small-bowel atresia, associated with decongestant use.