2005N-0137 Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
FDA Comment Number : EC59
Submitter : Ms. Cherry Wunderlich Date & Time: 09/28/2005 05:09:19
Organization : ThyCa: Thyroid Cancer Survivors' Association, Inc.
Category : Consumer Group
Issue Areas/Comments
GENERAL
GENERAL
Dear FDA Staff,

I am a thyroid cancer patient and a volunteer Board Member of ThyCa: Thyroid Cancer Survivors' Association, Inc. ( www.thyca.org ). I'm also ThyCa's Outreach and Publications Coordinator.

I write to ask that you reconsider and change your proposed rule that allows pharmacies to change the brand of levothyroxine sodium given to a thyroid patient.

My doctor, who is a thyroid cancer specialist, has advised me to stay on the same brand to keep the TSH at the level needed for my circumstances with my thyroid cancer.

I do not favor or oppose any particular brand of levothyroxine sodium. However, I oppose allowing a pharmacy to change the brand. They are not bioequivalent when it comes to control of thyroid cancer.

If a pharmacy changes the brand, thyroid cancer patients must then incur the expense and time burden of a blood re-test to determine whether their blood TSH is at the very narrow appropriate level needed to prevent growth or recurrence of their thyroid cancer.

In dozens of talks by thyroid cancer specialist physicians at ThyCa's International Thyroid Cancer Survivors' Conferences, and other ThyCa events, the specialists agree that it is essential not to change brands. The doctors do not recommend or oppose any particular brand of levothyroxine sodium. They do recommend staying on the same brand to ensure TSH suppression in the very narrow range needed.

ThyCa's web site also has a page titled Know Your Pills: ( www.thyca.org/knowpills ). It explains that thyroid cancer specialist physicians recommend staying on the same brand of levothyroxine sodium.

Thank you for your consideration of this matter.

Cherry Wunderlich
10113 Parkwood Terrace
Bethesda, Maryland 20814

Board Member, ThyCa: Thyroid Cancer Survivors' Association, Inc. ( www.thyca.org )