|2005N-0137||Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting|
|FDA Comment Number :||EC6|
|Submitter :||Dr. Lawrence Wood||Date & Time:||05/26/2005 01:05:39|
|Organization :||Thyroid Foundation of America|
|Category :||Health Care Association|
| To the FDA:
I am enclosing information in a survey done on the website of the Thyroid Foundation of America regarding changes in thyroid hormone medication that have occurred since the FDA ruled that all thyroixine products were bioequivalent.
We believe that the experiences of these patients in this random survey (any patient that was switched to another brand of thyroxine was asked to participate regardless of any other factors).
I look forward to presenting this data at the FDA hearing on May 23, but wanted you to have the data in advance for your records.
Lawrence C. Wood, MD, FACP_
Medical Director, Thyroid Foundation of America
Changing Thyroid Medications - A Questionnaire for Patients - Survey Results
The physician was noted as the person advocating the change in prescription less than half the time.
Even more important and of real concern is the fact that follow-up TSH tests were abnormal in 85 of the 121 patients reporting. A higher TSH would mean inadequate thyroid suppression in anyone who has thyroid cancer and needs suppression of TSH to help prevent recurrence or spread of the cancer. A lower TSH could mean hyperthyroidism and an increased risk of serious heart arrhythmias, especially in individuals over the age of 50 and those with underlying heart disease. Finally, it is noteworthy that 62% of the patients reporting felt worse on the new medication, and nearly 60% expressed dissatisfaction with the result.
We at TFA are grateful for the opportunity to share these data with representatives of the FDA and endocrine physician groups at the upcoming hearings.