Health

Pharmacists across the country are being asked to educate patients about a newly identified risk associated with long-term use of common allergy medications cetirizine (Zyrtec) and levocetirizine (Xyzal). The Food and Drug Administration (FDA) issued a warning on May 23, 2025, detailing rare but severe cases of persistent itching – known as pruritus – experienced by individuals after discontinuing these antihistamines. This development underscores the importance of patient counseling regarding potential withdrawal effects, even with over-the-counter medications.

The FDA’s alert focuses on patients who have been taking cetirizine or levocetirizine daily for extended periods – typically several months or even years – and did not experience itching before starting the medication. Whereas the occurrence is rare, reported cases have been serious, requiring medical intervention to manage the widespread and intense itching. The agency is revising prescribing information for prescription versions of the drugs and will request manufacturers update the Drug Facts labels for over-the-counter formulations to include this risk. Understanding this potential side effect and proactively informing patients is now a critical component of responsible pharmacy practice.

Understanding the Pruritus Risk

Cetirizine and levocetirizine are second-generation antihistamines widely used to treat allergic rhinitis (seasonal and year-round allergies) and chronic idiopathic urticaria (chronic hives). Approved for use in adults and children as young as two years old, these medications work by blocking histamine, a chemical released by the body during allergic reactions. Yet, the FDA’s recent communication highlights a previously unrecognised consequence of prolonged use and subsequent discontinuation. The exact mechanism behind this withdrawal-related pruritus remains unclear, but the FDA is actively investigating the phenomenon.

According to the FDA, the itching experienced after stopping these medications is not simply a return of allergy symptoms. Instead, it’s a distinct adverse reaction that develops specifically after ceasing long-term use. Cases have been reported in individuals using both prescription and over-the-counter forms of the drugs, emphasizing the need for broad patient education. Pharmacists are uniquely positioned to deliver this information, particularly given their frequent interactions with patients seeking allergy relief.

Pharmacist’s Role in Patient Counseling

The FDA recommends that healthcare professionals discuss the risk of pruritus with patients when prescribing or recommending cetirizine or levocetirizine, especially if chronic use is anticipated. This conversation should also include patients who are already using over-the-counter versions of the medications. Pharmacists can play a vital role in initiating this discussion during dispensing and over-the-counter consultations.

Key counseling points should include:

• Awareness of the risk: Inform patients that stopping these medications after prolonged use may, in rare cases, lead to severe itching.
• Prompt reporting: Advise patients to contact their healthcare provider if they experience intense itching after discontinuing cetirizine or levocetirizine.
• Gradual tapering (potential): While not specifically recommended by the FDA, pharmacists can discuss the possibility of a gradual tapering schedule with the prescribing physician, although the effectiveness of this approach is currently unconfirmed.

The American College of Allergy, Asthma, and Immunology (ACAAI) has also released resources to aid healthcare professionals in discussing this issue with patients, including speaking points and links to the FDA’s official communication. Learn more about the ACAAI’s guidance here.

Looking Ahead

The FDA continues to monitor reports of this adverse event and will provide updates as more information becomes available. Pharmacists should stay informed about any further guidance from the agency and professional organizations. This recent safety warning serves as a reminder of the importance of ongoing vigilance and patient education regarding both prescription and over-the-counter medications.

This information is intended for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.

Have you discussed this new FDA warning with your patients yet? Share your experiences and insights in the comments below.

The American Academy of Pediatrics (AAP) has released findings that offer no new evidence to support recent changes in guidance regarding the hepatitis B (Hep B) vaccine for newborns. A study published in Pediatrics challenges recommendations issued last year by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) that suggested discouraging the birth dose of the vaccine for infants born to mothers who test negative for hepatitis B.

The debate centers on the initial dose of the Hep B vaccine, traditionally administered within 24 hours of birth. The ACIP’s revised guidance, adopted in August 2025, stemmed from concerns about potential overvaccination and a desire to align with international practices. Still, the AAP’s analysis indicates that altering this long-standing protocol isn’t currently warranted, raising questions about the basis for the shift in recommendations.

Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. According to the CDC, an estimated 2,200 people die each year from liver disease related to hepatitis B infection . The birth dose of the Hep B vaccine has been a cornerstone of preventing mother-to-child transmission of the virus, particularly in regions with higher prevalence rates.

Study Findings and ACIP Recommendations

The AAP study meticulously reviewed available data on the safety and efficacy of the birth dose Hep B vaccine. Researchers found no compelling evidence to suggest that delaying or omitting the initial dose provides any significant benefit and potentially introduces risks. The study specifically examined the impact on infants born to mothers who tested negative for the hepatitis B surface antigen (HBsAg).

The ACIP’s June 2025 recommendations, which were adopted by the CDC Director on August 4, 2025, proposed that infants younger than 8 months born during or entering their first respiratory syncytial virus (RSV) season, and who are not protected by maternal vaccination, receive one dose of clesrovimab. The committee also stated there was no preferential recommendation between nirsevimab and clesrovimab . However, the AAP’s new findings specifically address the Hep B vaccine and do not directly relate to the RSV recommendations.

Implications for Immunization Schedules

The AAP’s findings are likely to fuel further discussion among healthcare professionals regarding the optimal Hep B vaccination schedule. The current recommended childhood and adolescent immunization schedule, published by the AAP, is revised annually to reflect the latest vaccine recommendations . The organization’s stance could influence future updates to these schedules.

Healthcare professionals can access all CDC recommended immunization schedules through the CDC Vaccine Schedules app, optimized for tablets and smartphones . These schedules guide providers in determining the appropriate vaccines for each age group, taking into account factors such as medical conditions and risk factors.

What’s Next in Vaccine Guidance?

The ongoing evaluation of vaccine recommendations highlights the dynamic nature of public health policy. The ACIP regularly meets to review new scientific evidence and adjust guidelines accordingly. The next ACIP meeting will be crucial in determining whether the committee will revisit its recommendations regarding the Hep B birth dose in light of the AAP’s study. Continued monitoring of hepatitis B incidence rates and vaccine effectiveness will also be essential in shaping future guidance.

This information is for general knowledge and informational purposes only, and does not constitute medical advice. It is essential to consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.

What are your thoughts on the evolving Hep B vaccine recommendations? Share your comments below, and please share this article with your network.