Genentech Inc. and U.S. regulators have added a warning about the risk of a certain type of anemia with the biotech company’s Raptiva drug for psoriasis, according to a letter made public Wednesday.
The company and the Food and Drug Administration also strengthened warnings about the risk of serious infections and decreased blood platelets that may be associated with Raptiva, said the letter to doctors dated Friday.
Raptiva won U.S. approval in October 2003 to treat adults with chronic moderate-to-severe plaque psoriasis, a skin condition noted for its red, scaly patches.
Since then, two cases of hemolytic anemia, which is caused by premature destruction of red blood cells, were reported. Two other cases were earlier reported in a clinical trial, according to the letter posted on the FDA’s Web site.
Genentech spokeswoman Tara Cooper said such reports were rare, but the company felt the four cases warranted a warning on the label.
Serious infections, including bacterial sepsis and severe pneumonia, and infections that worsened even with antimicrobial treatment were also reported after approval, the letter said.
Cooper could not say how many cases of infection there were, but said they were consistent with clinical trials. "They’re very low numbers," she said.
A copy of the letter is online at www.fda.gov/medwatch/safety/2005/raptiva-deardoc-071205.pdf/
