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FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections

Posted on: 9/8/08

According to a press release from the FDA: "The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died."

To read the full release, click here.

Our Medical and Scientific Advisory Board issued the following statement:

A key piece of information is that these are not new occurrences that are being reported, but a clarification on what types of infections need to be carefully looked for in patients on TNF inhibitors. Doctors will now have a better idea of what to watch for and test for if the patient is sick with signs and symptoms of an infection.

The new warnings improve your doctor's ability to find an infection that might be lurking.

Amgen and Wyeth also released a press release in regards to the FDA's announcment. Their press release can be read by clicking here.


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