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
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