For no particular reason, I’ve recently become familiarized with the story of Diclegis (Diclectin in this study, and in Canada). For use in pregnancy-induced nausea and vomiting, Diclegis is a delayed-release combination formulation of 10mg each of doxylamine and pyridoxine. It was approved by the FDA in April of 2013, and has rapidly become first-line therapy.
The surprising bit – this is precisely the same drug our mothers took in pregnancy. It was introduced in the 1950s as Bendectin, and it was estimated as many as 30% of pregnant women took this combination pill in the 1970s. However, in the early 1980s, the manufacturer was the target of innumerable lawsuits alleging fetal malformation – and in 1983, voluntarily withdrew the drug from the market. This choice was made solely due to the costs of defending against litigation, and not a reflection of the safety of the drug. The physicians who had published data suggesting fetal risk were eventually discredited, and even the FDA noted in 1999 that Bendectin was not withdrawn for reasons of safety or effectiveness.
So – now it’s back, and, unsurprisingly, it works better than placebo. This manufacturer-sponsored, double-blind, placebo-controlled trial demonstrated improvement with Diclectin in almost every measure. And, 48% of Diclegis users asked for compassionate use of the study drug following conclusion of the study (although, so did 32% of placebo). I’ve also discovered my new favorite disease-severity scoring system: the PUQE Score.
The downside: it costs ~$160 for 30 pills.
A brief perusal of the internet shows doxylamine, a sedating, first-generation antihistamine costs as low as 3 cents per tablet. Pyridoxine, vitamin B6, costs as little as 6 cents per tablet. Diclectin costs ~$5 per tablet. You could pay for Diclegis – after all, it is a special “delayed-release” formulation where doxlyamine reaches peak concentration 6 hours after ingestion. Or, you could do what obstetricians have been telling their patients to do for the last several decades: make your own equivalent dosing from the component medications at a fraction of the cost.
It certainly seems prudent to try the cheaper option, first.
“Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial”
http://www.ncbi.nlm.nih.gov/pubmed/20843504