FDA reprimands Wyeth for unsubstantiated claims

7/25/2008

WASHINGTON The Food and Drug Administration has informed Wyeth Pharmaceuticals to stop using a BeneFIX flashcard suggesting, without sufficient evidence, that its hemophilia B drug is safer than CSL Behring’s Mononine.

A table on the front of the card compares BeneFIX, Original BeneFIX and Mononine implying both recombinant products are safer than the plasma-derived one, according to the agency’s June 30 letter to Wyeth. All three drugs are approved to control or prevent hemorrhages in patients with hemophilia B.

The table’s claim of safety superiority—“Low diluent with recombinant safety”—is emphasized by statements on the back of the card, giving the impression the product has no viral risk compared with Mononine, which the card implies is virally unsafe, the letter says. But plasma-derived products are virally safe when made properly, and recombinant products may have viruses from using animal sources, according to the letter.

None of the six points made on the card supports the safety claims, including three that refer to the drugs’ prescribing information, the letter says. Such claims must be supported by “substantial evidence or substantial clinical experience,” the letter adds.

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