Sins of Omission by Drug Companies Pose Dangers to Your Health

A pediatrician might have read the latest article citing the effectiveness of Diflucan as a way to treat ringworm, a childhood skin infection; however that same doctor wouldn't be aware that the FDA rejected Diflucan for the treatment of ringworm.

With the results from test data, the FDA decided that Diflucan was not an effective form of treatment for ringworm and found it could also pose risks to the liver when taken in high doses.

How did This Potentially Dangerous Drug get Past the FDA?

Due to the structure of the FDA labeling guidelines, when the FDA denies approval for the use of a new drug, that drug company doesn't have to disclose any negative testing findings on the label. This is what happened in the case of Diflucan and ringworm.

The labeling issue has stirred heated debates among several physicians over the failure to disclose all the findings from tests that were performed on the drug's effectiveness and its possible side effects. The main concern of the doctors was unknowingly prescribing potentially risky drugs to their patients. Drug companies have gotten around not being approved by the FDA by enclosing a medical print out with the drug that reads that the drug's safety and effectiveness "has not been established" in children.

The results from two tests that ran on Diflucan showed that it wasn't any more effective than the older generic version of the drug called griseofluvin, which was also capable of causing toxicity risks. The results also revealed that children could be placed at risk of developing liver problems if placed on higher doses of Diflucan.

Diflucan was able to make its way to pharmacy shelves without being tested because the FDA didn't approve it as a ringworm treatment.

The Ledger.com July 21, 2004