FDA Issues Alert, Announces Recall of Common Thyroid Medication

A pharmaceutical manufacturer voluntarily recalled a common thyroid medication because some doses were found to be subpotent.

IBSA issued a recall notice for 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level, according to the U.S. Food and Drug Administration. The drug is used to treat hypothyroidism (underactive thyroid).

Thyroid hormones control the rate at which a person burns calories and how fast the heart beats, according to a WebMD report. Underactive thyroid glands produce too little thyroid hormone to control those activities.

“The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots,” a IBSA statement explained.

Patients with underactive thyroid treated with subpotent TIROSINT®-SOL, may experience symptoms that may include, fatigue, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight, according to the company statement.

The Swiss-based pharma company said in its statement that retailers, health care providers and wholesalers will be notified to stop distribution of the recalled products. IBSA warned patients to speak with their doctors before discontinuing use of the recalled medicine.

“Patients who are currently taking TIROSINT®-SOL should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription,” the company spokesperson said in the statement.

“Any patients including those who might be pregnant, newborn infants, or elderly patients, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” the pharmaceutical company added in the statement.

Affected lot numbers, product codes and expiration dates are listed on the FDA’s website. The recalled drug is a clear, colorless to slightly-yellow solution in a white 1 milliliter ampule.

“Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation [or] medications or removed by surgery,” WebMD stated on the website. “Having enough thyroid hormone is important for normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as thyroid cancer).”