2005N-0137 Levothyroxine Sodium Therapeutic Equivalence; Notice of Public Meeting
FDA Comment Number : EC4
Submitter : Dr. Lily Agrawal Date & Time: 05/26/2005 01:05:51
Organization : solo practice
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a clinical Endocrinologist and am not affiliated with any of the companies making any medicines. Patients with thyroid disease require careful & long term monitoring of their disease to avoid over or under treatment. I would hate to do harm from the medicine I prescribe. Yet it bothers me very much when my patient's levothyroxine preparation (I use several based on patient preference/insurance coverage etc)is changed by local & mail order pharmacies without my approval. Often this comes to light at their follow up visit when they have been taking the "new pill" for 3-6 months and the tests come back abnormal. Upon questioning & looking at their bottles I realize they were given a generic alternative! All sorts of little tricks are used such as "if this box is not checked, a generic alternative will be substituted".
I feel this drug has a narrow therapeutic index and dose ranges fall between 12.5-25 micrograms. Hence even a tiny change can be very meaningful clinically. I fully support various companies rights to make this drug but we have to be sure they are therapeutically equivalent before giving it to patients. In a busy office where I am trying to cover the many aspects of patient's needs, the thyroid being only 1 of them, I could do without having to also be a detective and make sure my patient was given the right drug each time their pill bottle was changed. Until we can be ABSOLUTELY certain that a finite number of available preparations are EXACTLY equal as far as dose, availability,shelf life, color additives, other "inert" substances etc., I strongly feel we the clinicians and the patients have a right to choose which therapy we feel is best for our patients and they should not be altered at other people's whims (be it a drug company, pharmacy, insurance etc)in order to make a buck!