FDA Approves Over-the-Counter Claritin
November 27, 2002
FDA has approved Claritin (loratadine) as an over-the-counter (OTC) allergy drug product. Previously available only as a prescription drug, Claritin is approved for seasonal allergic rhinitis -- a condition that causes runny nose, nasal congestion, sneezing, and itchy nose, throat, eyes, and ears.
"By making it easier to get this widely-used drug, today's action will enable many people to get less-sedating, effective relief for their allergy symptoms more quickly and at a lower cost," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription."
Claritin's approval for OTC marketing was based on FDA's criteria for determining appropriate drugs for OTC use - namely that the drug in question treats a condition that consumers can diagnose and manage themselves; that the drug is sufficiently safe for use by consumers without direct prescriber supervision; and that the drug's label explains potential adverse effects and conditions of use with clear and understandable directions.
Claritin, however, has been linked to several disorders, including but not limited to, respiratory illness and irregular heartbeat. In April 2002, the European Medicines Evaluation Agency (EMEA) announced it was conducting a safety review of the drug after receiving an alarming number of reports from Sweden of birth defects in children born to mothers who used Claritin while pregnant. An investigation is still ongoing. Officials with Schering-Plough say the cases simply "constitute random events".
-- Article Courtesy of InjuryBoard.com
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