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Thyroid Patient Advocacy Group Warns Thyroid Patients of Potential Problems With Thyroid Drug Resulting From FDA Approval of Generic Versions

TFA is a member of the Alliance for Thyroid Patient Education

July 13, 2004

(FALLS CHURCH, VA) – The ATA Alliance for Thyroid Patient Education, an organization of leading patient education and advocacy groups, recommends that patients being treated with levothyroxine — a drug used to treat hypothyroidism, or an underactive thyroid — not make any changes in their brand of medication without first discussing the benefits, risks, and outcomes with their doctors.

This recommendation follows a recent decision by the Food and Drug Administration (FDA) to approve generic levothyroxine preparations as equivalent to branded preparations. The FDA ruling means that generic levothyroxine products are now deemed to be equivalent in treatment outcome and safety profile as the branded product. When drugs are considered therapeutic equivalents, pharmacists can change a prescription from one brand to another, often without the patient or physician being aware of the change.

Levothyroxine is a drug recognized to have a narrow toxic to therapeutic ratio with significant clinical consequences of excessive or inadequate treatment. There are 12 tablet strengths of levothyroxine available that vary by as little as 9 percent in drug content, reflecting the close titration that is required for optimal patient management. Thirteen million Americans are on levothyroxine products and those especially susceptible to incorrect titration include the elderly, pregnant women and their developing fetuses, and those with thyroid cancer.

“Even though having access to generic drugs can result in lower drug costs for patients, ensuring safety and effectiveness should always be the number one priority when providing generic alternatives,” said Alan P. Farwell, MD, Alliance Chair, Associate Professor of Medicine at the University of Massachusetts Medical School, and a staff physician at UMassMemorial Health Care. “In this case, serious questions have repeatedly been raised about the methodology used by the FDA to determine bioequivalence between branded and generic levothyroxine preparations, which can result in dangerous health problems in some individuals.”

Despite assurances to the endocrinology medical community that the concerns regarding the limitations in current levothyroxine bioequivalence standards would be addressed before ruling on generic levothyroxine approval, the FDA made its decision without input from clinical endocrinologists, the recognized experts in this area and those who care for thyroid patients.

As a result of the FDA decision, the ATA Alliance is providing guidance for patients through a statement posted on the ATA web site, www.thyroid.org, including recommendations that patients to take charge of their health by:

1. Knowing which brand of levothyroxine that their doctor prescribes and asking to stay that brand;
2. Being aware that pharmacists may change their brand when a prescription is filled and, therefore, checking prescription before leaving the pharmacy;
3. Asking their doctors to check their thyroid-stimulating hormone (TSH) levels in four to six weeks to determine if dose retitration is needed, in the case of a change in the brand of levothyroxine.

“We cannot emphasize enough the importance of staying on the medication that is specifically prescribed for Graves’ Disease patients,” said Nancy Patterson, of The National Graves’ Disease Foundation. “To change medications, especially without medical supervision, can be dangerous. The careful monitoring of one’s thyroid status is vital to maintaining optimal health.”

Joan Shey, President and Founder of the Light of Life Foundation, a group that focuses on thyroid cancer, also commented that “Thyroid health is a partnership between the patient and doctor. Patients should always check their prescription to be sure that it is filled by the pharmacy as the doctor wrote it. The bioequivalency level has to be exactly the same from prescription to prescription because the synthetic hormone is used to suppress any residual microscopic tumor that may be left behind.” She added, “TSH levels are maintained at a level optimal for controlling the cancer, balanced with the need for thyroid hormone due to surgical removal of the thyroid gland.”

The ATA Alliance for Thyroid Patient Education, an organization supported by the American Thyroid Association, is composed of the following thyroid patient education and advocacy groups: Thyroid Foundation of America, ThyCa: Thyroid Cancer Survivors Association, National Graves’ Disease Foundation, and the Light of Life Foundation. The mission of the ATA Alliance is to standardize and validate information provided to patients about the diagnosis, evaluation and treatment of thyroid diseases, based upon evidence-based, unbiased, non-anecdotal, accurate data and provided for the patient’s best interest. The ATA Alliance supports patient education and public awareness of thyroid disease.

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