This Widely Prescribed Thyroid Medication Was Recalled by the FDA

Hyperthyroidism affects 5% of the US population. This condition strikes people who are mostly 60 years of age and older. This chronic condition demands that those who need it take thyroid medication for life. Medication helps control their thyroid levels.

The FDA is a reputable organization for assessing food labels, ingredients, and drug potencies. Over the years, the FDA has recalled many foods because of mislabeling and undeclared ingredients.

In medication, it is primarily the potency that the FDA examines and recalls the drug. FDA recalled a commonly prescribed thyroid medicine on February 1, 2023.

Keep scrolling to find out which widely prescribed thyroid medication the FDA has recalled.

1. What Is This Medication Prescribed for?

Levothyroxine sodium is one of the most common thyroid medication names. Doctors prescribe it as a replacement therapy.

It is also used for suppressing pituitary thyrotropin. Additionally, in treating thyroid cancer, doctors prescribe this medication in combination with others.

The FDA recalled the thyroid medication with this generic name, manufactured by IBSA Pharma Inc. The name of the medication was TIROSINT-SOL.

2. What Was the Reason Behind Its Recall?

The FDA discovered issues with the potency of the drug. The issue was that the affected batches of thyroid medications had lower dosage strengths than those listed. Quite a few batches had this issue. To be specific, the FDA recalled 27 batches of the drug.

The medication is either colorless or slightly yellow. The company sells it as an ampule that contains 1 milliliter of the drug. The box of the ampules states the dosage strength. Additionally, the color of the label is also a distinguishing factor for the potency level.

A lower potency of the thyroid medicine means the patient would not get the recommended dosage. As a result, they would feel the effects of hyperthyroidism. Here are the effects that patients could experience:

– Swollen face

– Hair loss

– Constipation

– Swollen thyroid gland

– Sensitivity to cold temperatures

– Low heart rate

– Unexpected weight fluctuations.

3. How Was the Recall Process? 

Because the batch size is large, many people’s first thought is to discontinue the medicine. However, the FDA has advised that those who take TIROSINT-SOL for their hyperthyroidism or cancer treatment should not stop.

This is because this will affect the thyroid treatment they are receiving. The FDA has alerted IBSA Pharma Inc. to notify healthcare providers and distributors of this mislabeling.

The first step is that the patient goes to the doctor to replace the medication with another until the FDA has succeeded in recalling all products in the batch. Until now, no one has reported any medical emergencies because of the medicine.

Some people may have experienced mild hyperthyroidism symptoms. So, it is possible that they ignored these symptoms because they weren’t aware of the mislabeling of the thyroid medication.

Final Words

The FDA has played an active role in testing drugs, food items, and medications over the past several years. This time the FDA has found a lower potency drug mislabeled as a higher potency.

So, those whose doctors prescribe a higher potency but receive a lower one are likely to experience signs of hyperthyroidism. There are no life-threatening effects of the medication.