The FDA, now that they have had time to analyze Terbutaline for these off-label uses, has issued a severe warning against using Terbutaline to delay or stop premature labor contractions. They found it to be ineffective in doing so and that it poses serious health risks for both the mother and child.

When the FDA approves a drug, they simply approve that it is ‘safe’ to use. What most people do not realize is that doctors can use FDA approved drugs for purposes unspecified by the FDA. Terbutaline is a perfect example of this. This is a drug that was FDA approved to treat asthmatic conditions and COPD (chronic obstructive pulmonary disorder); however, doctors began using Terbutaline because they thought it was helpful in stopping premature labor contractions.

This practice is referred to as ‘off-label use’. In general, off-label use refers to the practice of prescribing drugs for any unapproved use, unapproved age group, unapproved dosage, or unapproved form of administration. Off-label use is actually a fairly common practice.

The FDA, now that they have had time to analyze Terbutaline for these off-label uses, has issued a severe warning against using Terbutaline to delay or stop premature labor contractions. They found it to be ineffective in doing so and that it poses serious health risks for both the mother and child when the drug is administered for longer than 72 hours.

Side effects for the mothers can include lung and heart damage and even death. Side effects for the children can include cognitive difficulties, speech defects, and an increased risk for brain damage.

A new Terbutaline Claims Center has recently been established to help protect the victims of Terbutaline. The goal is to stop additional woman and children from having to endure these terrible side effects from a drug that is not only ineffective, but incredibly unsafe. They also try their best to compensate the victims of Terbutaline in the process.