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Drug Safety

FDA reports cases of allergic contact dermatitis from topical doxepin

Published in Medical Letter on the CDC and FDA, April 13th, 2003

The Food and Drug Administration's postmarketing surveillance experience indicated that allergic reactions to 5% doxepin cream can occur if used beyond the recommended time period.

According to a study from the United States, "A total of 26 postmarketing cases of allergic contact dermatitis to doxepin 5% cream were reported to the Food and Drug Administration."

"Our findings suggest that allergic contact dermatitis was more common when treatment duration exceeded the recommended 8 days," said Renan A. Bonnel and collaborators at the Food and Drug Administration. "Allergic contact dermatitis to doxepin cream should be considered in patients whose...

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