June 4, 2001

SOURCE: American Thyroid Association, The Endocrine Society, and Thyroid Cancer Survivors' Association

WASHINGTON, June 4, -- The American Thyroid Association, The Endocrine Society, and ThyCa: Thyroid Cancer Survivors' Association are urging that the Food and Drug Administration (FDA) maintain the uninterrupted availability of Synthroid and other currently marketed thyroid hormone (thyroxine) products to the 13 million U.S. patients who rely on them every day for life to treat hypothyroidism, thyroid cancer, and other thyroid conditions.

The three professional and patient advocacy organizations are responding to recent media reports claiming that the FDA may soon take actions to remove Synthroid from the U.S. market.

Two-thirds of patients who take thyroxine are prescribed Synthroid, the first branded thyroxine preparation, which has been on the market for more than 40 years. Synthroid is the third most commonly prescribed drug in the U.S.

The organizations are concerned that patients who take Synthroid or another particular brand of thyroxine would suffer from the unnecessary discontinuation, even temporarily, of their prescribed formulation.

``Even the threat of an interruption could cause alarm, inconvenience, and cost for patients who are doing well on their current thyroid medication,'' said Paul W. Ladenson, M.D., Secretary of the American Thyroid Association. ``The American Thyroid Association, The Endocrine Society, and ThyCa are also concerned that patients could be harmed medically if they were forced to switch from one brand to another without appropriate monitoring and, when needed, dose adjustment.''

The three organizations express confidence in the FDA's well-established, reliable procedures for assuring the safety and effectiveness of all prescription drugs. Every brand -- including Synthroid -- and generic preparation of thyroxine has met those standards as they have evolved. In 1997, the FDA first determined that each thyroxine manufacturer would have to file a New Drug Application (NDA). Abbott Laboratories, the maker of Synthroid, has indicated its intent to file an NDA by the August 2001 deadline. King Pharmaceuticals, the maker of Levoxyl, and Watson Pharmaceuticals, the maker of Unithroid, secured FDA approval earlier this year.

The American Thyroid Association, The Endocrine Society, and ThyCa recognize that the reason that Synthroid and some other thyroxine preparations have not yet received FDA approval is logistical, not medical. Founded in 1923, the American Thyroid Association is a professional society of 900 U.S. and international physicians and scientists who specialize in the research and treatment of thyroid diseases. The Association is dedicated to promoting scientific and public understanding of the biology of the thyroid gland and its disorders, so as to improve methods for their prevention, diagnosis, and management. The Association fosters excellence in research, patient care, and education of patients, the public, and the medical and scientific communities. The Association also guides public policy about the prevention and management of thyroid diseases. The Association's web site is http://www.thyroid.org.

Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and to the clinical practice of endocrinology. The Endocrine Society's membership consists of over 9,000 scientists, physicians, educators, nurses, and students, in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Bethesda, Maryland. To learn more about the Society and the field of endocrinology, visit the Society's web site at http://www.endo-society.org.

Founded in 1999, ThyCa: Thyroid Cancer Survivors' Association, Inc., is an all-volunteer nonprofit organization, advised by a medical advisory council made up of renowned thyroid cancer specialists, offering support and information to thyroid cancer survivors, families, and health care professionals. ThyCa provides a network of free support services and resources to thyroid cancer survivors, families, and friends worldwide. ThyCa also sponsors Thyroid Cancer Awareness Week (the third week of September) and an annual International Thyroid Cancer Survivors' Conference. ThyCa's web site is http://www.thyca.org.