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Collagen products must carry new warning.
FDA Consumer
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December 1, 1991
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COPYRIGHT 1991 U.S. Government Printing Office. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group.
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A warning about an increased incidence of the diseases polymyositis and dermatomyositis (PM/DM) in people who have received collagen injections must be added to the products' labeling, FDA told Collagen Corp. of Palo Alto, Calif., in a letter last September. Collagen, regulated as a medical device under FDA laws, is injected under the skin to correct acne scars and wrinkles.
Because PM/DM are such rare diseases, the vast majority of collagen recipients won't be affected, FDA said.
The cause of PM/DM is unknown, but the diseases, which affect the body's ...
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