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In utero exposure to antidepressants not tied to eye malformations.(News)
ROCKVILLE, MD. -- To date, the Food and Drug Administration has not identified a recognizable pattern of congenital eye malformations in babies exposed to antidepressants during pregnancy, in a review of adverse events reported to the agency.
But the FDA will continue to monitor the Adverse Event Reporting System (AERS) database for such reports, said Dr. Solomon Iyasu, medical team leader in the division of pediatric drug development in the FDA's Center for Drug Evaluation and Research.
Dr. Iyasu provided an update at a meeting of the FDA's pediatric advisory subcommittee of the Anti-Infective Drugs Advisory Committee. At a meeting of the same panel in February, one case of an eye malformation (congenital ptosis, eye muscle paresis, and nystagmus) was reported in a baby exposed to the antidepressant citalopram (Celexa) in utero, during the year after citalopram was granted "pediatric exclusivity" by the FDA.
Since the February meeting, the FDA's Office of Drug Safety has searched the AERS ...
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- Newspaper article from: The Daily Mail (London, England) November 16, 2009 700+ words
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- Newspaper article from: The Daily Mail (London, England) November 16, 2009 700+ words
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