Labor Induction Drug Under FireNov 30, 2004 | www.cbsnews.com
Kelsey Cruts struggles with the little things. At four years old, she can barely walk, talk or sit up. But as CBS News Correspondent Sharyn Alfonsi reports, that's not the worst part.
"We believed what happened to our daughter could have been prevented had we been informed about the medication beforehand," says her mother Marlana Cruts.
The medication is called Cytotec. The tiny pill has been hailed as one of the most popular and effective labor inducing drugs, ever.
But what Kelsey's mother didn't know and what most women are never told is that Cytotec isn't approved by the FDA for labor induction. It's meant to treat ulcers.
Even the drugs own manufacturer says it should never be used on pregnant women.
"I was shocked," says Cruts.
You only need to look at the label to see why.
"I can look at this and say you shouldn't use it on a pregnant woman, but apparently the doctor didn't care," says Kelsey's father, Phillip.
Dr. Marsden Wagner is a retired chief of neonatology for the World Health Organization. He says one in every five pregnant women will be induced and Cytotec increases their risk of a uterine rupture.
"Think blownout tire," says Wagner. "The uterus actually ruptures wide open during the labor and when this happens it's an obstetrics catastrophe.
"Many women die and one out of four babies will die if that happens."
Others, like Kelsey, suffer severe brain damage. Mark Mueller is the Cruts' attorney.
"We call it 'Cytobomb' because the effects on the uterus are like a small bomb going off," says Mueller. "It's dangerous. We think it should be done away with."
But the American College of Obstetrician and Gynecologists disagrees. It's published its own guidelines supporting the use of Cytotec and says doctors who violate those procedures are the ones whose patients have problems.
If it's not FDA approved and the drug manufacturer says don't use it, why is it being used?
"The short answer is it works and works better than the other available agents and in the right context it seems to be safe," said Dr. Charles Lockwood of Yale University.
Ultimately, it's up to the doctors, not the FDA. What you might not know is that any doctor can use any drug on the market anyway they see fit. It's called "off label use" and it's quite common.
"Almost no drug used in obstetrics is labled for use in obstetrics," says Lockwood.
Lockwood says drug companies fear liability so they often don't test for use on pregnant women. That keeps the cost of the drug down. The FDA approved drugs for induction cost hundreds of dollars. Cytotec costs just 20 cents.
"I think I would have paid a whole lot more money for something else," says Phillip Cruts.
But the Cruts say they were never given that choice and now it's Kelsey that continues to pay.