Bendectin: A schizophrenic drug that isn t for schizophrenia

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In today s so what? news, a UCLA study found that a 60-year old morning sickness drug that is pretty close to useless (and was once withdrawn due to birth defect concerns) is significantly linked to an increase in adverse outcomes among newborns, and with problems in mothers as well.

A more fundamental question is why we are even reading about this.

The UCLA study concluded that antihistamine use to control nausea and vomiting during pregnancy was associated with low birth weight babies and premature births. The antihistamine in question is almost always Bendectin a drug with a checkered history at best. It is a combination of doxylamine (Unisom) and vitamin B6. And it s just a plain old lousy drug as a sleep aid, antihistamine, and antiemetic.

Bendectin was first approved in 1956 to control nausea and vomiting during pregnancy. It didn t work very well, and later there was considerable controversy about whether it caused birth defects. The drug was subsequently examined in two-dozen studies involving 200,000 women, and the birth defect issue seemed to be completely unfounded.

>But this didn t stop the lawyers. Bendectin (doxylamine/vitamine B6) was voluntarily removed from the market in 1983 by its manufacturer, Merrell Dow Pharmaceuticals as a result of multiple lawsuits alleging that it caused birth defects, even though an FDA panel found that there was no association between Bendectin and birth defects.

Subsequently, the FDA re-approved the drug in April of this year.

ACSH s Dr. Josh Bloom wonders why any of this is happening. He says, Not to belabor the obvious, but it is not unreasonable to expect that at some point during the past 60 years an improved drug (and this is not difficult in this case) would be discovered. He continues, And that is exactly what happened. In 1991, Glaxo Wellcome (now GlaxoSmithKline) launched Zofran (odantsetron) a revolutionary drug specifically designed to target specific serotonin receptors in the brain and gut that are responsible for chemotherapy-induced nausea and vomiting. Zofran is a miracle drug, and oncologists will tell you that it completely revolutionized cancer chemotherapy by taming GI symptoms from even the worst regimens.

Zofran has subsequently been approved for postoperative nausea and vomiting and radiation-induced vomiting and is used off-label (with great success) for severe morning sickness (called Hyperemesis gravidarum) and viral gastroenteritis. Kate Middleton was treated with Zofran during her pregnancy, as have many other women.

Dr. Bloom continues, With the discovery of far superior drugs to treat severe morning sickness, I m puzzled why anyone even cares what Bendectin does or doesn t do. Rather than taking this, you might as well just eat Pez.