Drug unapproved by FDA saves an infant’s life

Perflubron, a drug currently not approved by the U.S. Food and Drug Administration (FDA), just saved a four-month-old girl’s life.

Tatiana, the infant, was born in critical condition. Her doctors soon realized that the baby had inhaled meconium, or amniotic fluid mixed with stool, causing her lungs to collapse.

Elise and Bruce Saiaana, the parents, were told of the seriousness of the condition and that their daughter might not survive the ambulance ride to Seattle’s Children’s Hospital, CBS News reported.

When Tatiana arrived at the hospital, she was immediately put on an ECMO (extracorporeal membrane oxygenation) machine, which kept her heart beating and lungs breathing for about a month. However, doctors weren’t sure the infant could survive without the aid of the machine.

“She was still fighting, so we had to fight for her too,” said Elise Saiaana to CBS affiliate KIRO. “Once they took her off she would probably go instantly.”

The family was effectively out of options save for one: perflubron. The unapproved drug is an oxygen-rich liquid that expands the lungs before evaporating, according to CBS News. The drug was tested in the 1990s, but was eventually withdrawn when manufacturers found it wasn’t beneficial enough as a liquid ventilator.

Tatiana’s doctors obtained a waiver to use perflubron as a final effort to save the girl’s life. The drug had no effect right away and the parents prepared once more to lose their daughter. However, Tatiana soon began to show signs of improvement. After a short time she was breathing on her own and the baby was able to come home for the holidays.

“If it wasn’t for that drug, then there would be nothing left to do for her, said Elise. “The gift of having her home is the only gift we wanted this Christmas.”

Tatiana’s parents hope that their story will help to get perflubron approved by the FDA for children like their daughter. The drug is currently approved for use in Canada and Europe.

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