The U.S. Food and Drug Administration (FDA) on Thursday announced the recall of a thyroid medication after it was found that lots of the drug may be “subpotent.”
IBSA Pharma Inc. confirmed it is recalling Tirosint-SOL, or levothyroxine sodium, a medication used to treat an underactive thyroid gland. It said that the “voluntary recall has been initiated because these lots may be subpotent,” stated the announcement, published on the FDA’s website.
“The company’s analyses show a slight decrease below 95.0 percent of its labeled amount in levothyroxine sodium (T4) for some lots,” according to the recall notice. The recall doesn’t apply to Tirosint capsules.
People who take the recalled, subpotent drug could “experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, 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,” the notice said.
Other side-effects, it said, may include “negative effects” on bone metabolism, reproductive function, cardiovascular function, growth and development, gastrointestinal function, cognitive function, emotional state, and glucose and lipid metabolism, the company said.
But so far, the company hasn’t received any reports of adverse events associated with the recalled lots of the drug. The medication was distributed to the consumer level.
IBSA Pharma Inc., a Swiss-based company, said it is issuing notices to retailers, health care providers, and wholesalers to stop distribution of the recalled products.
The firm stipulated, however, that people “who are currently taking Tirosint-SOL should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription,” according to the release. “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,” it added.
The lot numbers, product codes, and expiration dates are available on the FDA’s website. The drug is a clear, colorless to slightly yellow solution that is supplied in a white 1 milliliter ampule.
According to health website WebMD, levothyroxine is used to treat an underactive thyroid gland and replaces or provides more thyroid hormone. For example, those who are treating thyroid cancer or who are in remission often have to take levothyroxine.
“Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation [or] medications or removed by surgery,” the website states. “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).”