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Collagen Maker Rejects FDA Finding on Rare Diseases

September 13, 1991

PALO ALTO, Calif. (AP) _ A company that makes injectable collagen on Friday rejected a Food and Drug Administration finding that product users have a higher rate of two rare diseases.

Frank DeLustro, vice president of scientific affairs for Collagen Corp., said the company’s natural protein products have proven safe. Collagen has been used to treat allergic reactions for decades, he said.

Collagen, a natural bovine protein, is injected under the skin to smooth wrinkles and repair acne and scars.

The FDA had previously rejected the notion that collagen is linked to the rare diseases. But on Thursday in Washington, FDA officials told a House subcommittee that collagen users do have a 75 percent higher incidence of two connective tissue diseases.

″We do see a statistically significant association,″ the FDA’s James Benson said during a hearing on FDA enforcement activities.

That preliminary finding looked at seven cases of polymyositis and dermatomyositis reported among the nearly 400,000 people who have used the collagen products, Zyderm or Zyplast. In the general population, the incidence of those diseases is one in 100,000.

FDA spokeswoman Susan Cruzan cautioned that more study is needed to determine if the finding is meaningful.

Polymyositis is an inflammation of muscles, usually in the shoulders and pelvis, which leads to weakened muscles. When the inflammation is accompanied by swelling of the skin, the disease is known as dermatomyositis.

DeLustro said the sampling of seven cases was too small to make conclusions about any links between injectable collagen - which the FDA approved in 1981 - and the rare connective tissue diseases.

″Our data shows that the incidence of these auto-immune diseases among collagen-treated patients is not significantly different than one would expect in the general population,″ DeLustro said.

If further federal studies prove the link between collagen and the diseases, the FDA could ban the sale of collagen products or require more strict labeling, officials said.

Last month, FDA officials seized $5 million worth of collagen-filled syringes from the company because it had deleted nine words from labels that warned collagen might be harmful to people with connective-tissue diseases. The company said the omission was an accident.

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