Asthma updates: FDA mulls pregnancy registry

September 1, 2009
Jeff Ryan

FDA thinks its important for the health of both a pregnant mother and her fetus to learn about a drug?s adverse effects: but is it?

It's important for the health of both a pregnant mother and her fetus to learn about a drug's adverse effects, especially for common drugs like those used to treat asthma. That's the Food and Drug Administraion's take: it wants to study on the subject.

The study wouldn't be a straight clinical trial but a "pregnancy registry": pregnant woman with asthma (and later their newborns) will be examined to see if any adverse events were seen, and which drugs they took during their pregnancy for their asthma. This is obviously a sensitive topic, so FDA is encouraging comments on how to minimize the pregnant women's participation, how best to run such a registry, and whether such a registry is even necessary.

Also from FDA, new language has been added to three companies'; leukotrine-modifier asthma drugs, to reflect new data about psychiatric effects the drugs may have. Merck's montelukast sodium (Singular), Cornerstone Therapeutics'; zileuton (Zyflo and Zyflo CR), and AstraZeneca's zafirlukast (Accolate) will mention more adverse events, including aggression, agitation, dream abornialities and hallucination, and insomnia.

Finally, researchers reporting in PLOS Genetics studied the genomes of 492 Mexican children with asthma to determine if they shared any novel genes. They found a target: the chromosomal 9q21.31 region. Mexican people have a proportionally low rate of asthma, which may explain why there haven’t been many studied on genomes about this common disease in this population. Plus, asthma is influenced by both genetics and environment, so the low incidence could be based on nongenetic lifestyle issues.