Florida Residents

Important Resources:

Mylan Pharmaceuticals vs. Department of Health, Board of Pharmacy, and Board of Medicine ruling
Presentations from AACE, ATA, and TES
A joint statement issued from AACE, ATA, and TES

The American Association of Clinical Endocrinologists (AACE) is deeply concerned about the Florida ruling in the Mylan Pharmaceuticals vs. Department of Health, Board of Pharmacy, and Board of Medicine case (Click for PDF). Across the state of Florida, this ruling may adversely affect the well-being of many patients being treated for an underactive thyroid.  

That ruling, signed January 28, 2008, removed levothyroxine sodium from the negative formulary list. This means that pharmacists may now substitute generic levothyroxine sodium without physician or patient consent. Levothyroxine sodium is a synthetic substitute for regular thyroid hormone used to treat an underactive thyroid gland, also known as hypothyroidism.

Removing levothyroxine sodium from the negative formulary list is significant for the following reasons. Although all current approved formulations of levothyroxine are of high quality, each is unique and may vary significantly in potency despite identical pill strength labels. Therefore, substitution of one levothyroxine preparation for another may lead to changes in thyroid levels and result in taking too much or too little thyroid hormone. Taking too much or too little thyroid hormone can have serious consequences; particularly for the elderly, children, those with heart and bone disease, and those who are either trying to become or who are pregnant.

AACE is a strong advocate for protecting patient health. Since 2004 AACE, along with the American Thyroid Association (ATA) and The Endocrine Society (TES), have petitioned the FDA to address the methodology used to determine “bioequivalence,” the basis for substituting one levothyroxine preparation for another, and its potential negative consequences of substituting one formulation for another. Click here to view presentations from AACE, ATA, and TES). A joint statement issued from the three sister associations is available here.

The recent Florida ruling, coupled with the FDA’s reluctance to recognize that each formulation of levothyroxine sodium is unique, will have a negative impact on the welfare of patients with thyroid disease.  

So, what can be done? For physicians, the only way to ensure that a patient’s prescription or refill order is honored to specifications is for the physician to write "Medically Necessary" on the prescription.

Florida patients need to be aware of the issue when getting their prescription filled. Whenever levothroxine pills that are dispensed look different than the previously prescribed ones, patients should speak with their pharmacist and physician about this. After all, their health may be at stake.

Listen to the AACE Radio Public Service Announcement: