An FDA Warning For Moms To Be: Terbutaline Possible Dangers

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By Mia Bolaris-Forget

Premature babies are not uncommon but in an effort to guarantee that moms go to full term, new and potentially "dangerous" drugs are being administered. And, now the Food and Drug Administration is mandating stronger safety warnings for a popular treatment geared at preventing pregnant woman from giving birth before their time.

According to the FDA, pregnant women should not have more than three days worth of terbutaline , a treatment which has been linked to potential serious side effects including maternal heart problems and possible fatality....thus, warranting from the FDA the most serious type of warning to be added to the drug's label.

In addition, the FDA has also warned medical professionals against prescribing a pill form of the drug for "any treatment of premature labor." since it also has shown to be effective but carries similar risks.

The FDA gave the thumbs up to terbualine only with regard to treating specific respiratory conditions but medical professionals have since used the drug in dealing with preterm labor. They add that once the drug has FDA approval, doctors can pretty much use it however they think is appropriate.

The reality is many pregnant women are taking the drug for weeks via a terbutaline pump....mostly those carrying multiples who are at greater risk of preterm labor.

With that said, experts note that they feel it would be alarming to see the medication become even more popular and available, especially since it can often mean life or death.

According to the FDA 16 deaths among pregnant women have been reported between 2009 and 1976, when the drug first hit the market.
In that time the agency identified 12 cases of serious heart problems reported to the agency between 1998 and 2009. As per these statistics, the FDA has deemed the drugs side effects to be greater than its benefits, especially with prolonged treatment either via injection or the pill. In addition, they feel that there is not adequate substantial evidence that the medication "really" works and is worth the risks.

While serious side effects and heart problems are rare, the drug frequently presents other side effects, including making women feel jittery and increasing heart rates and making it difficult to sleep.
The new FDA warnings reflect similar concerns also addresses in a letter sent to doctors back in 1997.

However, some doctors still sing the drug's praises and suggest the when used "properly" it "is" effective.

Officials at Alere, a company that distributes terbutaline pump therapy were not available for comment.

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