FDA on Drugs

. Friday, September 5

The FDA is in the news today on two drug fronts. Today, it started to list prescription drugs under investigation for potential safety problems, with the intent to inform doctors and people alike. Last year, Congress ordered the FDA to post drugs that the agency is currently investigating in an effort to be more open to the public about what it is, exactly, that they are doing. The list is titled "Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System" meaning that the FDA has identified a potential risk, but not necessarily a causal relationship between the drug and the risk.

Curiously, the FDA today ordered a stronger warning for four drugs commonly used to treat rheumatoid arthritis that are not on their drug list. In 240 cases, people taking Enbrel, Remicade, Humira or Cimzia developed a fungal infection called histoplasmosis, and 20% died because the diagnosis of the infection may have been late or overlooked entirely. Patients taking these arthritis drugs should call their doctors if they develop flu-like symptoms as these may actually be symptoms of histoplasmosis instead.