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6/4/2001

Counterfeit Somatropin Products Found

Kate Traynor

Serono Inc. and Genentech Inc. have separately issued warnings that counterfeit versions of the companies’ somatropin products have appeared on the market.

Serono reported the discovery of a new counterfeit lot of Serostim 6-mg vials in May. This is the second counterfeit lot of Serostim to surface this year. Serostim is used to treat cachexia, a wasting syndrome, in AIDS patients.

According to Serono, the counterfeit material is similar in appearance to the true product but bears the lot number MNH605A. Any product bearing this lot, said Serono, is "definitely not Serostim." The company said it is sending a "Notification of Counterfeit Product" letter to pharmacies, wholesalers, physicians, and AIDS service organizations.

For more information on counterfeit Serostim, call Serono at 888-275-7376.

The existence of counterfeit material posing as 10-mg vials of Genentech’s Nutropin AQ was also announced in May. Indications for Nutropin AQ include treatment of growth hormone deficiency in children and adults and treatment of short stature in patients with Turner’s syndrome. According to Genentech, some of the counterfeit product has been found to contain insulin and may be a "serious health risk" to patients who use the material.

Each vial of counterfeit Nutropin AQ bears one of three lot numbers—L9504A2, L9101A4, or L9404A3—also found on genuine vials of the product. Genentech has made available at its Web site an extensive list of features clinicians can use to distinguish the true product from the counterfeit versions. Some of the more obvious differences are:

Lot number typeface. The lot number and expiration date stamped on the counterfeit vials use a rounded typeface. In particular, the numerals 2, 4, 5, and 9 contain curves. The typeface used for the lot number and expiration date on the genuine vials is angular, with no curves.

Patient insert. The counterfeit product contains a patient insert printed on thick, white, "normal stock paper." The genuine product contains a patient insert printed on thin, off-white paper.

Product appearance. The counterfeit material is cloudy when stored at room temperature but clear when refrigerated. Lot L9504A2 of the genuine product is clear at both of these temperatures.

Genentech has asked anyone who believes they have obtained counterfeit Nutropin AQ to contact the Food and Drug Administration at 888-FDA-INFO.