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FDA warns of dangers of drug used to prevent premature birth

Terbutaline is a popular treatment used by doctors in an attempt to help pregnant women carry a pregnancy to full term. But the Food and Drug Administration is now requiring that the drug carry a "black box warning" indicating that the drug carries a serious risk of serious or life threatening side effects. According to the FDA, terbutaline has the potential to cause "serious maternal heart problems and death."

Despite the warning from the FDA, some support its use to avoid premature delivery, particularly for women who will be giving birth to twins or triplets. The director of a support group for families of triplets hopes that this will not lead to the drug becoming unavailable. In an article from USA Today she says that the drug has made a life or death difference for many pregnant women.

Currently many women receive terbutaline continuously for weeks prior to delivery through a pump system. The FDA now says that women should not receive injections of the drug for more than three days. The agency also says that the pill form of the drug should not be used at all, as it has not been shown to be effective and carries the same risks as the injections.

A researcher for the FDA indicated that the drug was not proven sufficiently effective to justify the risks. Beyond the risk of heart problems, the FDA also pointed to numerous risks that while less severe, are much more common. These include difficulty sleeping, increased pulse rates, and reports of women feeling jittery.

Source: USA Today "FDA flags risks on popular drug used during pregnancy" Alison Young, February 18, 2011

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