The Food and Drug Administration is considering requiring achange in the labeling of Collagen Corp.'s injectable bovinecollagen products, the company said Tuesday.
The FDA met last week with the National Institutes of Health,the Centers for Disease Control and the Texas Department ofHealth to discuss the relationship between injectable bovinecollagen and two rare autoimmune diseases, polymyositis anddermatomyositis, known as PMD.
Polymyositis is an inflammatory disease of skeletal muscle.Dermatomyositis is a form of polymyositis occurring inconjunction with inflammatory skin lesions.
The Palo Alto, Calif., company already mentions those diseasesin its labels.
Collagen officials met Tuesday with the FDA, but the outcomeof the talks was not disclosed.
In the past 10 years, 13 suits have been filed against Collagenclaiming that its products have caused autoimmune diseases,mostly PMD. The first was settled out of court, 10 have beenresolved in Collagen's favor and two are pending.
"I wouldn't think (a labeling change) would have any impact onexisting lawsuits," said David Foster, vice president of financeand administration. "Publicity in and of itself can alwaysgenerate new lawsuits, but with all the publicity in the lastsix months, we haven't had any new lawsuits filed against us."
Collagen stock (NASDAQ:CGEN) closed at $19, down $1.50, onTuesday.
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