U.S. Probes Claritin Link to Birth Defects
U.S. regulators are investigating whether Schering-Plough Corp.’s allergy drug Claritin may be linked to birth defects reported in Sweden, a health official said.
Swedish authorities have noted a higher-than-expected number of cases of hypospadia, a malformation of the penis, among children whose mothers took Claritin while pregnant. European authorities announced Thursday they had launched a safety investigation at Sweden’s request.
The defect can be corrected through surgery.
Dr. Maryanne Mann, an official with the U.S. Food and Drug Administration, said the agency was not aware of any reports of the condition in the United States.
Schering-Plough said both Claritin and its newer drug, Clarinex, a derivative of Claritin, are safe.
Mann said agency officials were reviewing previous animal studies of Claritin to try to determine whether it could be linked to the birth defects. Officials also are reviewing information from birth registries in the United States.
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