The U.S. Food and Drug Administration has issued a Drug Safety Communication warning patients, consumers, and health care professionals about the rare occurrence of severe itching (pruritus) after stopping long-term use of the oral allergy medicines cetirizine or levocetirizine. This serious itching has been reported in patients who discontinue these medicines after using them daily, typically for a few months to years. Patients did not experience itching before starting the medicines.  

 As a result, we are revising the prescription cetirizine and levocetirizine prescribing information to include a new warning about this risk. We will also request that manufacturers add a warning about pruritus after stopping the medication to the Drug Facts Label (DFL) of over-the-counter (OTC) cetirizine and levocetirizine.

More information is available in the Drug Safety Communication.