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FDA Demands Tougher Warnings on Immunosuppressive Drugs
Date:9/4/2008

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Authorities also looked at one reported case of histoplasmosis in a patient taking Cimzia. There have also been reports of other fungal infections, notably coccidioidomycosis and blastomycosis, some fatal, in patients taking these drugs.

The FDA is already in the middle of a safety review of TNF blockers, including an investigation into whether or not the drugs are linked with the development of cancer, particularly lymphoma, in children and young adults. "We have a six-month timeline for that review, and we intend to meet that timeline," Siegel said.

All the drug labels already include information about possible fungal infections, but authorities expressed concern that the issue wasn't highlighted appropriately.

"We've been concerned about the possibility of serious infectious since we initially approved these drugs, and it has been in the labeling since the beginning," Siegel said. "Warnings about serious infections have included fungal infections. What's new is that we became aware that some physicians may not be considering the possibility of fungal infections early enough, so we want to raise awareness. So far, companies have been fully cooperating with efforts here."

"We don't want to give the impression that these conditions were neglected," Siegel continued. "They're hard to diagnose, and they can mimic other conditions. We think the new message is that people weren't aware that this might happen but that it is under-diagnosed and important to identify."

The manufacturers are required to submit labeling changes within 30 days or to outline reasons as to why labeling changes are not necessary.

Doctors and patients should be on the lookout for persistent fever, cough, shortness of breath and fatigue. Any patients experiencing these symptoms, especially if they live or have traveled to areas where the fungus is endemic, should seek medical attention immediately.

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