This Wednesday, the Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health, published a health alert concerning a drug, Solsint, used in the treatment of thyroid function disorders such as hiccups and hyperthyroidism.
More specificallythe alert refers to two batcheswhose distributed units have already been withdrawn from the market and returned to the laboratory in a precautionary manner.
The lots affected
According to the agency, the alert is due to a “possible result out of specifications in the content of the active ingredient levothyroxine”, which constitutes “a Quality defect that does not pose a vital risk to the patient”.
Los lots affected son:
- SOLSINT 112 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85610, CN: 729891). Batch: 220852, expiration date 02/29/2024
- SOLSINT 13 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85613, CN: 729897) Batch: 220751, expiration date 01/31/2024
- SOLSINT 150 MICROGRAMS ORAL SOLUTION IN UNITED PACKAGES, 30 single-dose containers (NR: 85614, CN: 729899). Batch: 220857, expiration date 02/28/2024
- SOLSINT 200 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85616, CN: 729903). Lot: 220860, expiration date 02/28/2024. SOLSINT 75 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85619, CN: 729910). Lot: 220853, expiration date 02/28/2024.
- SOLSINT 88 MICROGRAMS ORAL SOLUTION IN UNIT-DOSE CONTAINER, 30 unit-dose containers (NR: 85620, CN: 729912). Batch: 220854, expiration date 02/28/2024
What Solsint is and what it is used for
Solsint is a commercial presentation of the levothyroxine, a synthetic form of thyroxine used as a hormone replacement for it. It is used as a replacement for thyroid hormone deficiency in cases of an underactive thyroid gland (hypothyroidism) and as concomitant therapy during treatment of excess thyroid hormones (hypothyroidism).
It also serves to prevent recurrent episodes of goiter (abnormal enlargement of the thyroid gland) after surgery in patients who retain normal thyroid function, to treat cases of benign goiter in patients with normal thyroid function, and for the treatment of certain tumors of the thyroid gland, especially after surgery. Finally, it is also used in the diagnostic field in the thyroid suppression test.
The thyroid gland is a small, butterfly-shaped gland located in the front of the neck. Its job is to produce hormones that control how the body uses available energy, and therefore its function affects phenomena such as breathing, heart rate, weight, digestion or mood. Thus, alterations in thyroid function can have consequences such as heart, bone, muscle, menstrual cycle or fertility problems.