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FDA Raises Safety Warnings against Popular Drug Prescribed During Pregnancy

FDA Raises Safety Warnings against Popular Drug Prescribed During Pregnancy


The Food and Drug Administration flags risks on a popular pregnancy treatment to prevent pregnant women from giving premature birth. According to FDA, pregnant women must not take the drug terbutaline (as injections) for more than three days. FDA is raising stronger safety warnings against this pregnancy drug "because of the potential for serious maternal heart problems and death". This pregnancy drug is now requiring the most serious type of warning that FDA can add to a drug's label boxed warning. In addition, FDA warned the doctors, gynecologist and obstetricians against prescribing the pregnancy drug terbutaline in both forms (injections and pills) for "any treatment of preterm labor". Even the pill form of this pregnancy drug carries similar risks and is yet to prove its effectiveness.

FDA approves Terbutaline only for treating specific respiratory conditions; however, many doctors have been prescribed this drug to treat preterm labor. The general practice is that once FDA approves a drug, doctors can use it for treating any medical conditions they deem appropriate. Similarly, many gynecologist and obstetricians has been prescribing terbutaline for pregnant women.

Many pregnant women received this drug through a terbutaline pump continuously for weeks. Some strongly support the use of this drug on pregnant women who are carrying twins and triplets, as they are at higher risk of giving premature birth. Janet Bleyl, the founder and president of the Triplet Connection, which is a national group supporting parents of multiples said, "It would be alarming to me to see it become unavailable. It has made a life-or-death difference for many, many of our families."

According to FDA, 16 deaths among pregnant women were reported between 1976 and 2009. And terbutaline was first marketed in 1976. The agency identified that 12 cases of serious heart events were reported between 1998 and July 2009. In addition, FDA "has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women". If a pregnant woman continues with terbutaline injections or the drug in pill form for a prolonged period, it may have adverse effects. Though many gynecologist and obstetricians as well as pregnant women believe that this drug helps in prolong pregnancy, John Thorp who helped FDA for Healthcare Research and Quality said, "there's no proof of effectiveness," after reviewing the scientific evidence.

This drug hardly causes serious heart problem; however, terbutaline may routinely trigger other side effects. Pregnant women who are using this drug may have difficulty sleeping, fast heart rates and feel jittery. In 1997, the federal agency sent in a letter to doctors with similar concerns. Cynthia Pearson of National Women's Health Network said, "I hope the FDA's new warning will help us finish the job that got started with that letter". The National Women's Health Network petitioned the FDA to take steps against this drug back in 1996.

However, some doctors still believe that this drug has several benefits in treating pregnant women. John Elliott, an expert on multiple-birth delivery at Saddleback Memorial Medical Center in Laguna Hills of California said, "If you use the tool effectively, it will work."

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FDA Raises Safety Warnings against Popular Drug Prescribed During Pregnancy