The Food and Drug Administration is now requiring stronger safety warnings for a popular treatment to prevent pregnant women from prematurely giving birth.
Women should not be given injections of the drug terbutaline for more than three days “because of the potential for serious maternal heart problems and death,” the FDA said Thursday. It is now requiring a boxed warning — the FDA’s most serious type of warning — be added to the drug’s label.
The FDA also warned doctors against prescribing a pill form of the drug for “any treatment of preterm labor” because it has not been shown to be effective and carries similar risks.
The FDA has approved terbutaline only to treat specific respiratory conditions, but doctors have widely prescribed the drug as a treatment for preterm labor. Once a drug has been approved by the FDA, doctors can prescribe the drug for any use they deem appropriate.
Many women receive it continuously for weeks through a terbutaline pump. Its use is strongly supported by some advocates for women carrying twins and triplets, who are at higher risk of giving birth prematurely.