The U.S. Food and Drug Administration (FDA) has released an updated safety warning regarding two commonly antihistamines, cetirizine (Zyrtec) and levocetirizine (Xyzal). These medications are among the most frequently used allergy treatments worldwide and are available both by prescription and over the counter. They are prescribed for seasonal and perennial allergic rhinitis as well as chronic urticaria, acting by blocking histamine, the mediator responsible for allergy symptoms. Typical side effects include drowsiness, fatigue, dry mouth, sore throat, cough, and occasional gastrointestinal discomfort.
The concern!!
Individuals who suddenly discontinue long-term daily use of these drugs may experience rare but severe generalized itching (pruritus).
The itching was not present before starting therapy.
Symptoms usually begin 2–5 days after stopping.
Most cases involved use for several months to years
FDA findings,
Between 2017 and 2023, 209 cases were reported.
Most patients had used the medication for over three months.
Although millions use these drugs, the reaction remains uncommon but clinically important.
Management and FDA action,
Restarting the antihistamine relieved symptoms in most cases; gradual tapering helped some patients.
The FDA is adding warnings to prescription labels, updating OTC labels, and advising clinicians to counsel long-term users.
Patient advice,
Seek medical guidance if severe itching occurs after stopping these medicines and discuss long-term use risks and benefits with your healthcare provider.
The adverse effects of suddenly stopping antihistamine therapy after a prolonged period of use can be prevented by doing so under the supervision of a physician who can monitor the process of tapering off the dosage.
These medicines are very common and are almost used by every other person , so people need to awared of this unwanted and uncommon side effect ; so that it is used in moderation and under the guidance of the physician.
Well said. These are the medicines which are very commonly used for allergic conditions. Proper awareness of allergy medicines usage prevents risks from overuse, especially given their common availability over-the-counter in India.
These drugs are over-the-counter (OTC) medicines that are easily available and often used without a prescription. Therefore, creating awareness about their proper use and potential risks is very important.
Very well explained. This FDA update highlights the importance of counseling patients on tapering long-term cetirizine or levocetirizine use, as abrupt discontinuation can rarely trigger severe rebound pruritus despite these drugs being widely considered safe.