FDA Issues Warning on Allergy Medications Linked to Severe Withdrawal Symptoms

Two widely used allergy medications may trigger severe reactions in some individuals when discontinued. The U.S. Food and Drug Administration recently released an alert concerning cetirizine, better known as Zyrtec, and levocetirizine, known as Xyzal. The warning highlights potential withdrawal symptoms following long-term usage.

The FDA cautioned that stopping these medications after extended use could lead to intense itching, referred to medically as pruritus. This symptom was primarily reported by patients who had consistently used these treatments for months or even years.

Since April 2017 until July 2023, the FDA recorded a total of 209 cases globally, with 197 occurring within the United States. “This figure only reflects reports received by the FDA, suggesting that additional cases may exist,” the agency stated.

The experiences logged showed that reported cases were rare but sometimes serious. Patients noted severe, widespread itching that necessitated medical intervention. The agency also noted that the condition significantly disrupts the quality of life and daily functioning of those affected.

In many cases—90 percent to be exact—patients found relief by resuming the medication after experiencing itching. Additionally, 38 percent of those who restarted the medication were able to taper off successfully afterward.

Availability and Usage of Allergy Medications

Cetirizine and levocetirizine are available through both prescriptions and over-the-counter options. The FDA indicated that it would modify the prescribing information for these drugs to reflect the potential risk of itching upon cessation. Manufacturers will also be instructed to include this information on the labels of over-the-counter versions.

Both medications have received approval from the FDA for treating seasonal allergies in adults and children aged two and older. They are also effective against year-round allergies and chronic hives for patients aged six months and up.

What to Do if Experiencing Withdrawal Symptoms

The FDA advises any individual who experiences severe itching after discontinuing these allergy medications to consult with a healthcare professional. This step is crucial for those considering long-term use, as the FDA emphasized the importance of discussing potential risks and benefits with a healthcare provider based on personal health needs.

Besides severe itching, other common side effects associated with cetirizine and levocetirizine include fatigue, drowsiness, dry mouth, fever, and gastrointestinal issues such as diarrhea and vomiting.

Expert Insights on Allergy Medications

Dr. Marc Siegel, a clinical professor of medicine at NYU Langone Health and a senior medical analyst for Fox News, commented that these medications are effective at relieving allergy symptoms. He reiterated that the FDA’s findings highlight a rare possibility of severe itching after long-term use. He speculated that this might be attributable to rapid histamine release once the antihistamine blocker is no longer in the system.

Industry Response to FDA Alert

A spokesperson for the Consumer Healthcare Products Association addressed the alert, emphasizing that consumer safety remains a priority. He stated that the over-the-counter industry endorses the FDA’s efforts to inform the public about safety signals, even when these occurrences are exceedingly rare.

Furthermore, the association reiterated the need for consumers who use these medications daily over extended periods—spanning months to years—to refrain from abruptly stopping their medication. Consulting with a healthcare provider before making any changes to medication is vital for safety and health.

Opella, the manufacturer of Xyzal, also released a statement affirming the medication’s solid safety and efficacy history, backed by scientific research. They described the withdrawal reaction as rare and reaffirmed their commitment to safeguarding patient health when the medication is used as directed.

Staying Informed and Safe

As the safety of patients remains a collective priority within the healthcare community, it is essential for individuals using cetirizine or levocetirizine to be aware of their health options. Bearing in mind the potential for withdrawal symptoms, users should take proactive steps, including discussing long-term use with healthcare professionals.

Patients need not only to manage their allergies effectively but also to be informed about medications that could lead to adverse effects when discontinuation occurs. Monitoring ongoing health developments will help ensure that patients remain safe and informed about their treatment options.

The FDA will continue to assess safety data concerning these allergy medications, providing updates as needed to protect public health. Staying proactive and informed will empower patients in their healthcare journeys while minimizing potential risks associated with allergy medications.