Millions take these allergy meds... now the FDA says they may WORSEN symptoms
An FDA warning has been issued over a new crippling side effect of allergy drugs taken by more than 60 million people worldwide.
The FDA says it has received complaints from patients who suffered from severe itching after stopping the oral allergy medicines cetirizine and levocetirizine - sold under the brand names Zyrtec and Xyzal.
These medicines are available in prescription and over-the-counter forms.
The itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years.
Patients did not experience itching before starting the medicines.
Pruritus in its most severe form can cause skin damage and open sores, with patients reporting distress and difficulty sleeping.
Health officials said the cases were 'rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention'.
As a result, the government agency is revising the prescription cetirizine and levocetirizine prescribing information to include a new warning about this risk.
Manufacturers will also be required to add a warning about pruritus to the drug facts label of the OTC versions.
An estimated 62.7 million packages of OTC cetirizine and levocetirizine products were purchased by consumers in the US in 2022.
Both medications can help relieve symptoms like sneezing, runny nose, itchy nose, and watery eyes caused by pollen and other seasonal allergens.
They can also be used to manage year-round allergy symptoms triggered by dust mites, pet dander, or mold.
Cetirizine was approved for oral use by prescription in December 1995 under the trade name Zyrtec (no longer sold as a prescription medicine) and approved for OTC use in November 2007.
Meanwhile, levocetirizine was approved for oral use by prescription in May 2007 under the trade name Xyzal and approved for OTC use in January 2017.
Patients have been advised to contact a health care professional if they develop severe itching after stopping prescription or OTC cetirizine or levocetirizine pills.
Those who reported the uncomfortable side effect, said the itching typically occurred within a few days of stopping the medicines.
Overall, the FDA says that it identified 209 cases of pruritus worldwide linked to cetirizine and levocetirizine cessation.
This number only includes reports submitted to the FDA so experts suspect there might be additional cases.
It notes that it is unsure why the medication causes the itching but 'many reports described widespread pruritus that required medical intervention after stopping these medicines, with a large number describing significant and persistent impact on quality of life and ability to function'.
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