Claritin Pharmaceuticals, which makes claritins for pain, has been facing backlash from some doctors and consumer advocates who say the drug has been mislabeled as an over-the-counter medication.
In a letter to the Federal Trade Commission, the company’s chief executive officer, Chris Dominguez, wrote that his company is confident in its product.
Dominguez says the drug is safe for use in treating chronic pain and that its label is accurate.
The drug is a prescription drug, not a generic drug, and has a lower risk of causing adverse effects.
The company says it uses proprietary formulations to minimize its risk.
The FDA has ordered Claritins to stop selling the drug to Medicare, Medicaid, the Department of Veterans Affairs, and some of the largest insurers, including Humana and Blue Cross Blue Shield of New Jersey.
The agency has been working with Claritings partners to address the labeling issues.
While claritine can cause serious side effects, it’s safe to use the drug for the majority of patients.
The FDA has warned patients to not stop taking the drug until after their first consultation.
A Claritini spokesman did not immediately respond to a request for comment.
For now, Claritinis brand name is used for generic versions of the drug that are not available in the United States.
Some doctors have questioned the safety of claritines and the possibility of overprescribing them.
The FDA says patients should be warned to stay on the drug and to be aware of their symptoms, but doctors have not recommended that patients stop taking it.
Clinicians should also check the label of clarithromycin, another generic version of claritonin, before prescribing it.
The labels are also sometimes updated to include the number of capsules a patient has taken.
This article is part of Fortune’s Health Care Insider series.