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Jun28
Briefly Noted: Talking About Drug Risks

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Those reading the papers this morning may have seen reports about two new studies published in the New England Journal of Medicine focusing on the use of antidepressants during pregnancy.  Here’s what the study authors had to say about the research:

-Study I: Use of Selective Serotonin-Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects

Study Conclusion: Maternal use of SSRIs during early pregnancy was not associated with significantly increased risks of congenital heart defects or of most other categories of birth defects. Associations were observed between SSRI use and three types of birth defects, but the absolute risks were small, and these observations require confirmation by other studies. (emphasis mine)

Study II: First-Trimester Use of Selective Serotonin-Reuptake Inhibitors and the Risk of Birth Defects

Study Conclusion: Our findings do not show that there are significantly increased risks of craniosynostosis, omphalocele, or heart defects associated with SSRI use overall. They suggest that individual SSRIs may confer increased risks for some specific defects, but it should be recognized that the specific defects implicated are rare and the absolute risks are small. (emphasis mine)

So, based on my reading of the data, women taking antidepressants early during pregnancy face a very small risk of their baby developing certain birth defects.  However, further studies are needed to determine the true danger.  

However, depending on what newspaper you read this morning, you may have gotten a very different impression – at least based on the headline.  For example, USA Today reported this: “Antidepressants May Raise Birth Defect Risk.”  On the other hand, the New York Times said: “Antidepressants Rated Low Risk in Pregnancy.”

Confused yet?  

This situation reminds me about what happened with Avandia.  Dr. Steven Nissen said: Avandia increases the risk of heart attack by 43 percent.  However, the drug’s manufacturer GlaxoSmithKline has argued:

-A meta-analysis is not the best way to evaluate a drug’s safety profile

-Nissen’s analysis is “fragile” because the study authors said: "A few [heart] events either way might have changed the findings for myocardial infarction or for death from cardiovascular causes. In this setting, the possibility that the findings were due to chance cannot be excluded.”

Unfortunately, not much can be done about how the media, scientists and others digest and communicate clinical data -- especially if they have a vested interest in the results.  In addition, with health literacy being so low in this country, we cannot depend on the majority of Americans to successfully interpret and apply the data.  No, all we can do is ensure that we communicate complexity as clearly as we can.

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