New Study Illustrates the Limitations of Compounded Thyroid Hormones

CHICAGO, Oct. 31, 2019 /PRNewswire/ -- A new study released today at the 89^th Annual Meeting of the American Thyroid Association (ATA) calls into question the pharmacy practice of creating custom made thyroid hormone formulations for individual patients. In a study conducted by Campbell University College of Pharmacy & Health Sciences, samples of liquid formulations of levothyroxine sodium, a commonly prescribed thyroid hormone, were obtained from 6 retail pharmacies in the United States that provide pharmacy compounding services. The samples were analyzed to determine if their labelled potency was preserved over a four-week period. Additional analyses included an evaluation of excipient ingredients used to create the formulations as well as instructions provided to patients.

According to the study's investigators, the compounded formulations demonstrated inconsistent product potency at each weekly observation period. "Levothyroxine is a narrow therapeutic index drug with potentially deleterious patient outcomes if administered in sub or supratherapeutic doses," said Dr. Charles A. Carter, lead investigator. "The inconsistent product potency exhibited by these compounded formulations should be of great concern to clinicians, patients and public health officials. Equally concerning is the wide number of excipient ingredients used to create these formulations, as well as, the widely divergent patient instructions for product storage provided," he added. "The recent availability of a commercially prepared liquid levothyroxine formulation renders these custom-made pharmacy preparations both unnecessary and undesirable."

The results of the study were presented today in abstract form at the 89^th Annual Meeting of the American Thyroid Association (ATA). Plans for publication are in place. The study was sponsored by IBSA Pharma, Inc., makers of Tirosint-SOL (levothyroxine sodium) solution. Tirosint-SOL® is the first and only levothyroxine liquid formulation available on the U.S. market. Made with only levothyroxine, glycerol and water for enhanced tolerability and absorption, the product is available in 12 dosage strengths packed in unique monodose ampules for precision and convenience. Tirosint-SOL is indicated as treatment of hypothyroidism for a wide variety of patients of any age.  Additional information, including money saving options for patients that can reduce of the cost of Tirosint-SOL to as little as $25 per month, can be found at www.Tirosintsol.com.

IBSA Pharma is part of IBSA Group, which is headquartered in Lugano, Switzerland. The company is a world leader in the treatment of thyroid disease and has a diversified product portfolio of prescription drugs. With products on five continents and in over 80 countries, IBSA has a commitment to scientific research and improving the health of patients. The appropriateness of this product along with important safety information should be discussed with a physician before use.

For more information, visit www.ibsagroup.com/media.  

*For Full Prescribing Information, visit www.Tirosintsol.com

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SOURCE IBSA Pharma, Inc.