FDA responds to terbutaline turf war
February 1, 1998 5 minutes read
FDA responds to terbutaline turf war
Sides still worlds apart on safety issue
Following a lengthy crusade and ultimately a petition filed with the Food and Drug Administration by the National Women’s Health Network (NWHN) in Washington DC, the FDA recently issued a statement addressing the subcutaneous administration, via infusion pump, of terbutaline sulfate for the treatment and prevention of preterm labor.
For well over a year the NWHN has fought such use. (See Home Infusion Therapy Management, May 1997, p. 68.)
"Our position was that because preterm labor is so complicated and not completely understood, to really show benefit, you need a comparative study with women who seem to be similar at the beginning of the study and then seeing if the pump made any difference," says Cynthia Pearson, executive director of the NWHN.
The FDA’s response to the NWHN’s petitions was, in part, as follows:
"In the absence of data establishing the effectiveness and safety of the drug/device, the FDA is alerting practitioners, home health agencies, insurance carriers, and others that continuous subcutaneous administration of terbutaline sulfate has not been demonstrated to be effective and is potentially dangerous."
Susan Cruzan, an FDA spokesperson, tells HITM that the two-page response to the NWHN’s petition went out to 40 health professional organizations.
"It is a recommendation from the agency that we don’t know about the use of this product in this manner," she says. "Essentially, the product is being used in an off-label manner, and the FDA does not regulate the practice of medicine."
However, Cruzan adds that the FDA does have authority over what manufacturers and health care organizations are doing. The letter notes that if a company is actively promoting the drug for a use that is not approved, that company would be in violation of promotion and advertising regulations.
In a press release, Matria Healthcare in Marietta, GA, a leading provider of terbutaline for tocolytic therapy and the most recognized opponent of the NWHN’s efforts, states that the company "neither prescribes nor advocates the use or non-use of any particular type of tocolytic agent and believes the use of particular treatments to be a private matter between patients and their physicians."
Cruzan confirmed that Matria, if simply following physician recommendations, is doing no wrong, as such actions are not under the FDA’s authority.
Not alone
Matria has its share of allies, including Sidelines National Support Network, a Laguna Beach, CA-based national non-profit organization that supports and educates women with complicated pregnancies.
Immediately after the FDA’s letter became public, Sidelines began it’s own push to thwart the effects of the negative press surrounding the subcutaneous administration via infusion pump of terbutaline sulfate for tocolytic therapy.
"There are physicians that have been using these pumps for nearly nine years," notes Candace Hurley, Sidelines executive director. "The fact is that the NWHN has opposed every treatment for preterm labor. We would love for there to be something better than what is out there now, but we know what prematurity does, and we don’t want these options taken away."
Hurley isn’t alone in her opinion that subcutaneous terbutaline is the best option for certain pregnant women.
"It’s safer than any tocolytic we use, and in certain cases, there’s no question it’s effective," says John Morrison, MD, professor and chair of the Dept. of Obstetrics/ Gynecology at the University of Mississippi Medical Center in Jackson, as well as a member of Sidelines’ advisory board. "I think it is helpful in appropriately selected high-risk patients, and the potential risk to the mother and the unborn child are smaller than anything else we could give them."
Don’t disregard use altogether
Morrison says that the bases of the NWHN’s arguments are unfounded. The NWHN bases much of its argument on the lack of studies particular to the subcutaneous terbutaline. But Morrison says that’s no reason to never use the drug in appropriate patients.
"Some of the studies have been small and may not have been blinded, or it may be a case-controlled study, and while all that is true, it doesn’t negate the fact that it was found to be helpful in 100% of those high-risk patients," he says.
Then there’s the death of a pregnant woman who died while receiving subcutaneous terbutaline. "I specifically reviewed that case, and the patient’s blood sugar level was incompatible with life, and if anything, terbutaline increases blood sugar, so it wasn’t related," notes Morrison. "I was infuriated with the NWHN because what they said was exactly opposite of what’s in the literature. They kind of cloaked it."
Morrison points out that only 3 mg of terbutaline is administered to the patient subcutaneously over any 24 hour period, although with regular infusion, a patient receives anywhere from 70 mg to 100 mg over 24 hours.
"It’s a cardiovascular drug, but if you’re going to have a fast pulse, which one is more likely to get you in trouble, 70 mg to 100 mg or 3 mg, spread out over 24 hours?" asks Morrison. "I thought it was strange because if you take 3 mg of terbutaline and give the whole daily dose at once, which is not possible with these pumps because it’s programmed, it wouldn’t be as much as we give in four hours to patients in labor."
Patients are monitored twice daily
Morrison adds that patients receiving subcutaneous terbutaline via infusion pump are monitored twice a day as well as have a nurse on call around the clock.
He also points out that the latest FDA release is nothing new.
"I attended the advisory committee meet- ing at the FDA, and this is almost word for word what they put out before, so nothing has changed since 1993," says Morrison. "They said at that time that physicians that used terbutaline in this manner were using it off label and had to weigh the possible benefits against the possible risk. So physicians should do just what the FDA has said, and that is to weigh the benefits and risks when they prescribe any off-label drug usage."
In the meantime, the NWHN will try to sway doctors away from this service.
"We want to continue our work to get the message directly to women because education doesn’t always change the behavior of the majority of physicians because they can stick with their old ways," says Pearson.
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