The American Thyroid Association (ATA), Endocrine Society, and American Association of Clinical Endocrinology (AACE) are disappointed with the FDA. The full force of 3 major societies came out against the FDA's ruling to approve generic T4 as equivalent to the brand name. That is a total of about 5000 clinical endocrinologists represented in those 3 societies. Why? T4 has a narrow toxic to therapeutic ratio. There is significant consequences of excess or inadequate treatment. Adverse effects of the wrong dose include:

1. Recurrence of symptoms
2. Osteoporosis
3. Atrial Fibrillation
4. Worsening of heart disease
5. Preterm delivery
6. High cholesterol

There are 12 strengths of T4. They vary by as little as 9% in T4 content. Close titration is required for optimal therapy.

13 Million Americans are on Thyroid Medication

They all are at Risk!
Incorrect dosing can effect the elderly, pregnant women, the fetus, and thyroid cancer patients the most.

Now, the patient and physician may not know the patient was switched off the brand before an adverse event occurs.

Previously in my newsletters, I have spelled out why the FDA is wrong about generics due to faulty methods to determine bioequivalence. All 3 societies urged further studies to answer serious defects. Well, the FDA, after giving us lip service, made the decision without our expert advice and consent.

What should you do now?

1. Be aware of planned aggressive switching at your drug store. They will tell you generics are equal.
   Do not believe them.
2. Demand a "do not substitute" Rx from your physician.
3. If you let them switch you, they you will need a retesting on the new generic.
4. This should make you mad, and cost you more money. If you stayed on the brand, you would not need another test.

A proper Brand only RX should be written to prevent the drug store from substituting a generic on you.

1. Have your physician write: "Synthroid", "brand only", "void if substituted"
2. Physician must initial the brand only line.
3. Then it is up to you to make sure the drug store does not slip you a generic.
4. They are not allowed to give you a generic when you have the above RX!
5. Tell them 5000 Endocrinologist disagree with the FDA on T4 generics.

Yours truly, and goodbye,