A company that makes injectable collagen Friday rejected a Food and Drug Administration finding that 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 diseases. But on Thursday in Washington, FDA officials told a House subcommittee that collagen users have a 75% higher incidence of two connective tissue diseases.
"We do see a statistically significant association," the FDA's James Benson said at a hearing on FDA enforcement activities.
The preliminary finding involved seven cases of polymyositis and dermatomyositis among nearly 400,000 people who have used the collagen products, Zyderm and Zyplast. In the general population, the incidence of the 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, usually in the shoulders and pelvis, that 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 a link between collagen and the diseases, the FDA could ban the sale of collagen products or require stricter labeling.