Botox Stops Lethal Saliva Buildup in Infant

Off-label use saves baby from invasive surgery

WEDNESDAY, Sept. 21, 2005 (HealthDay News) -- Botox, famous for erasing the wrinkles of the beauty-conscious, has recently saved a severely ill baby from undergoing tracheotomy to drain excess saliva from his lungs.

In what doctors say is the first time Botox has been used on such a young patient, a Montreal otolaryngologist eight months ago injected Botox into the salivary gland of a one-month-old whose saliva was accumulating in his lungs and constricting his breathing.

Within 10 days of the injection, the baby was taken off the ventilator he had needed to breathe, and is now at home and doing very well, reported Dr. Sam Daniel, who is the doctor who performed the procedure and director of the Saliva Management Clinic at Montreal Children's Hospital.

"I had enough experience and confidence in doing this procedure, but it wasn't an easy decision to make [on such a young child]," Daniel said. "There is scant literature on the topic, very few guidelines and no follow-up."

Yet, he said, the situation facing the baby was dire. Suffering from a rare genetic disorder called Charge Syndrome, the baby had multiple health problems, including possible blindness, and was on a ventilator because of the saliva buildup in his lungs. The normal procedure to treat the excess saliva is a tracheotomy, a surgery where a tube is placed permanently in the throat so that saliva can be regularly suctioned from the lungs by a machine attached to the tube.

The young parents, overwhelmed by their son's multiple health problems and the risks of surgery, considered withdrawing care from the baby rather than have him undergo the invasive surgery.

Following discussions with the parents, pastors at their church, the ethics committee at the hospital and medical experts, Daniel and his colleagues decided to try Botox injections, which had been successful on other children, although he had never performed a procedure on anyone younger than four years old.

"Deep in my heart I knew there was a good chance that it would work, and so we said, 'Let's give it a try,'" he said.

Daniel successfully paralyzed a major salivary gland, but left the smaller glands intact so the baby's mouth was left moist. The infant underwent a second injection two months ago -- Botox's effectiveness lasts for about six months, Daniel said -- and continues doing well.

"This is a procedure that actually has been very commonly done over the last five years, and there are pretty good studies on it, but what is unique is the age of the patient. The difficulty is knowing exactly the dose, as it is toxic, a poison," said Dr. Michael Shohet, an otolaryngologist at Mount Sinai Medical Center in New York City.

"But it's nice to see that we may be able to use it on younger patients which, for obvious reasons we've been reluctant to do because of the dosage," said Shohet, who uses Botox in his own practice to relieve a number of spastic disorders, such as twitching eyelids, and torticollis (also called cervical dystonia), a neurological movement disorder where muscle contractions force the head and neck into abnormal and sometimes painful positions.

While Botox has been approved by the U.S. Food and Drug Administration for various uses since 1989, including eye muscle spasms, torticollis and cosmetic treatments, the agency has not approved the substance for this latest use.

"Botox is very unique and doctors continue to conduct independent research to explore other potential uses," said Caroline Van Hove, a corporate spokeswoman for Allergan, Inc., the Irvine, Calif. manufacturer of Botox.

She said that the company is currently conducting FDA studies to have Botox approved to treat migraine headaches, overactive bladder, and post-stroke spasticity, but are not conducting trials at this time for its use in treating saliva glands.

In the meantime, however, Daniel is continuing to use Botox injections to treat excessive saliva buildup in children suffering from various diseases, such as cerebral palsy or hypotonia, which occurs when muscles are weak and unable to function properly.

"The major benefit is that we have another option to offer kids who have excess saliva secretion necessitating intubation. This is worth a try before offering something more invasive," he said.

More information

The FDA explains how Botox works.

SOURCES: Sam Daniel, M.D., director, Saliva Management Clinic, Mackay Rehabilitation Centre, Montreal Children's Hospital, McGill University, Montreal; Michael Shohet, M.D. assistant professor, otolaryngology and facial plastic surgery, Mount Sinai Medical Center, New York, N.Y.; Caroline Van Hove, spokeswoman, Allergan Inc., Irvine, Calif.
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