In early September, according to CNN, the Food and Drug Administration.
In early September, according to CNN, the Food and Drug Administration (FDA) recently ordered stronger warnings on four TNF-alpha blockers--which are widely used to treat rheumatoid arthritis, Crohn's disease, juvenile arthritis, certain types of psoriasis, and other conditions--cited for raising the risk of a possibly fatal fungal infection: histoplasmosis. These injectable drugs--Enbrel, Remicade, Humira, and Cimzia suppress the immune system to keep it from attacking the body. The FDA office that oversees arthritis drugs became concerned after discovering that doctors appeared to be overlooking the fungal infection. Of 240 cases reported to the FDA, 45 patients died. The FDA's order means that the risk of histoplasmosis will be flagged in a "black box," the strongest warning information in a drug's prescribing literature; the language varies from drug to drug.
Another CNN report last month detailed the government's posting of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. The basic warning system is a bare-bones compilation naming 20 medications and the potential risk for each. The list includes drugs whose problems have already been publicized, such as the blood thinner heparin and immune-suppressing medications as well as some drugs involved in overdoses perhaps linked to confusing instructions. Drugs will be placed on the list based on reports the FDA receives regularly from hospitals, doctors, and patients; the list will be updated each calendar quarter. The FDA cautions consumers to continue taking their medications, even if it appears on the list of drugs under investigation, until advised by their physicians to stop.
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|Title Annotation:||News; Cable News Network; laws on using of four TNF-alpha blockers|
|Publication:||Medical Laboratory Observer|
|Article Type:||Brief article|
|Date:||Oct 1, 2008|
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