The Food and Drug Administration Friday seized $5 million worth of collagen products that some physicians use to fill facial wrinkles and enlarge lips because it said the products' labels failed to warn that the drug poses a risk to sufferers of certain of connective tissue diseases.
The manufacturer, Collagen Corp. of Palo Alto, Calif., had deleted a phrase from the FDA-approved labels of Zyderm and Zyplast, according to the drug agency. As a result the label said that adverse reactions were possible in people who have rheumatoid arthritis or scleroderma. The missing phrase warned that adverse reactions may also occur in patients with systemic connective tissue diseases such as juvenile rheumatoid arthritis.The U.S. Attorney's Office in San Francisco filed a seizure action Friday on behalf of the FDA and 50,770 syringes loaded with collagen and worth an estimated $5 million dollars were taken into custody at the company's Freemont plant.
The seizure is viewed as part of a general campaign by FDA Commissioner David Kessler to step up the vigor of FDA enforcement of its regulations.
However, Collagen Corp. criticized the FDA's action and described it as an "extreme" response to what was "a minor clerical error."
Howard Palefsky, president of Collagen Corp., accused the FDA of victimization of the company. "This causes unnecessary fear for doctors and patients," he said. "We leave it to impartial readers to decide if the FDA . . . is seeking sensationalist publicity."