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FDA Issues New Warning on Allergy Drugs Zyrtec and Xyzal

Unexpected Side Effects Surface

The Food and Drug Administration (FDA) has recently issued a safety alert concerning two widely used allergy medications, cetirizine, commonly known as Zyrtec, and levocetirizine, known as Xyzal. On May 16, the agency announced that some patients who discontinued these drugs experienced severe itching, a condition medically termed as pruritus. This side effect was not present before the patients started using the medications and appears to be linked to long-term daily use, often spanning months or even years.

According to the FDA's findings, of the 209 cases reported globally, 197 were from the United States. The majority of these cases involved patients using one of the two drugs, while two individuals had been taking both simultaneously. The alert underscores the importance of awareness among users who might consider stopping these medications abruptly after prolonged use.

Impact on Patients and Recommendations

The severe itching reported by patients has prompted the FDA to update the warning labels on both Zyrtec and Xyzal to reflect this potential risk. Health professionals are now urged to inform patients about the possibility of pruritus upon discontinuation and to discuss strategies for safely tapering off these medications if needed. The agency has not specified a direct cause for this reaction but emphasizes monitoring and reporting any adverse effects to better understand the scope of this issue.

For those currently using these allergy medications, the FDA advises consulting with healthcare providers before making any changes to their regimen. This precaution aims to prevent unexpected reactions and ensure that alternative treatments are considered if necessary. The focus remains on patient safety and informed decision-making regarding the use of these common allergy relief options.

Ongoing Monitoring and Future Updates

The FDA continues to monitor reports of adverse effects related to cetirizine and levocetirizine through its adverse event reporting system. The agency is encouraging both healthcare providers and patients to report any instances of severe itching or other unusual symptoms following the discontinuation of these drugs. This data collection is crucial for updating safety guidelines and potentially uncovering additional information about why this reaction occurs.

As more cases are studied, the FDA plans to release further updates if new findings emerge. For now, the priority is ensuring that users of Zyrtec and Xyzal are aware of this newly identified risk and have access to guidance on managing their allergy treatment effectively and safely.

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