The American Association of Clinical Endocrinologists (AACE) objects to the recommendation from the National Organization of Women (NOW) and the Gray Panthers that the Food and Drug Administration (FDA) withdraw Synthroid, a thyroid medication, from the market. These organizations want Synthroid removed from the market until it demonstrates compliance with FDA safety and efficacy requirements. ``While AACE does not endorse specific products, it feels that this proposed action is extremely misguided and unwarranted,'' said Rhoda H. Cobin, MD, FACE, AACE President.
``Endocrinologists have prescribed Synthroid (levothyroxine) with confidence for the past 42 years,'' notes Dr. Cobin. ``The drug has a long record of safety, efficacy, reliability and consistency.''
Synthroid, like some other drugs including aspirin, marketed prior to 1962 were not required by the FDA to file a New Drug Application (NDA). The FDA recently notified Abbott Laboratories, makers of Synthroid, that either an NDA be filed or that evidence be submitted to show that the product is not a new drug and is generally recognized as safe and effective. Abbott requested a waiver of necessity for a New Drug Application (NDA), which was denied; therefore an NDA is being submitted.
The basis of the action of NOW and Gray Panthers is that the drug is not ``approved,'' despite its long and safe use. AACE strongly suggests that the request for drug removal be denied and that the ``in limbo'' status of Synthroid can be avoided by an expedited review process by the FDA, said Dr. Cobin.
AACE is greatly concerned that the precipitous removal of the drug would create a massive and expensive burden for both patients and physicians alike. Synthroid patients would have to visit physicians for an alternative medication. This would also require a significant change in pharmacy orders. Moreover, patients will be confused and unnecessarily alarmed over the safety of the drug. Dr. Cobin noted that clinical endocrinologists have not encountered unusual problems in prescribing Synthroid and, in fact, count on its reliability.
``This is not about favoring one product over another, but what is best for our patients and the least costly and burdensome for our health care system. Actions of this type are not helpful in either instance,'' says Dr. Cobin.
AACE is a professional medical organization with over 3,700 members in the United States and 65 other countries. Founded in 1991, AACE is dedicated to the optimal care of patients with endocrine problems. AACE initiatives inform the public about endocrine diseases. AACE also conducts continuing education programs for clinical endocrinologists, physicians whose advanced, specialized training enables them to be experts in the care of endocrine disease, such as thyroid disorders, diabetes, growth hormone deficiency, osteoporosis, cholesterol disorders, hypertension and obesity.
For further information on thyroid disorders and other endocrine disorders, or AACE guidelines visit the AACE web site.