To all:
It ain't easy!
This is to inform the people on the thread of a news article released last night that had some potential troublesome news for Matria. A group calling themselves the "National Women's Health Network" filed complaints to the FDA about a medical device that pumps terbutaline into women at risk of premature labor. Matria provides women with this equipment only when the woman's physician prescribes it.
This terbutaline delivery procedure has been around for a long time and has been used in homecare treatment as well as in hospital treatment many thousands of times. A couple of years ago, a pregnant woman who was using the system died, but to the best of my knowledge, she was a very ill patient to begin with.
I believe that in the short term, this news could cause some selling pressure on the stock. Matria is in the process of preparing a response, and I will let you know as soon as I hear anything. Below is a copy of the news release.
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The Associated Press
WASHINGTON (AP) - The Food and Drug Administration is warning doctors against prescribing an at-home device that thousands of women have used to fight premature labor, saying there's no evidence that it works and it can be dangerous.
The FDA also said it is investigating whether home health-care companies illegally promote at-home terbutaline pumps, which are not government-approved for use in pregnancy.
At least one expectant mother died while using a terbutaline pump, and the therapy also can cause chest pain, irregular heartbeat, shortness of breath or fluid in the lungs, the FDA wrote 40 medical societies last week.
Any woman now on a terbutaline pump ''should speak with her (health care) provider about whether it's necessary,'' advised FDA reproductive health chief Lisa Rarick.
At issue is a device that continuously pumps an asthma drug called terbutaline into women at risk of premature labor.
Hospitals widely use terbutaline intravenously for women in premature labor. Although the FDA has never approved this use of terbutaline, doctors can prescribe any medicine as they see fit.
But sending a woman home with a machine that pumps the potent medicine for days or weeks ''has not been demonstrated to be effective and is potentially dangerous,'' the FDA wrote doctors after investigating complaints filed by a consumer advocacy group, the National Women's Health Network.
''By informing doctors that there is no scientifically acceptable evidence that this drug-device system prevents premature birth, the FDA has safeguarded the health of many pregnant women,'' said network director Cynthia Pearson.
Matria Healthcare, a leading terbutaline pump supplier, did not return phone calls Wednesday. But the California company has said that it merely rents to women the terbutaline infusion equipment their doctors prescribed and that it hires nurses to telephone the women daily about side effects.
AP-NY-11-19-97 1908EST
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