June 1, 2001

SOURCE: Gray Panthers

WASHINGTON, DC June 1 -- The Gray Panthers sent a letter to Abbott Laboratories today asking the company to respond to U.S. Food and Drug Administration concerns regarding the safety and effectiveness of Synthroid, a drug used by millions of Americans to treat thyroid disease. The letter concluded: "Unless we receive satisfactory answers to the questions posed in this letter, we believe your product should be removed from the market."

The Gray Panthers' challenge to Abbott was issued in response to a letter from Abbott Vice President Dr. David Pizzuti in which the company insisted ``the safety and efficacy of Synthroid has been well supported.'' Senior and consumer groups are concerned that Abbott has failed to address the FDA's concerns expressed in an April 26, 2001 letter rejecting the company's GRAS/E petition to receive agency approval of the drug without putting it through the standard New Drug Application (NDA) process.

Synthroid has been on the market for many years without FDA approval. The FDA issued an order in 1997 stating that all levothyroxine sodium USP products (of which Synthroid holds 85% of the marketplace) must obtain NDA approvals. The agency acted after it determined that the products being sold demonstrated a ``lack of stability and consistent potency'' and had ``the potential to cause serious health consequences to the public.'' (Federal Register, August 14, 1997, Volume 62, Number 157).

Two other companies complied with the FDA directive and have received approval of their levothyroxine sodium products. In denying Abbott's petition, the agency stated:

1. ``Synthroid cannot be generally recognized as safe and effective because it is of no fixed composition."
2. ``Synthroid has a history of problems."
3. ``Patients taking Synthroid have experienced significant, unintended variations in their doses of levothyroxine sodium,'' and ``these variations are not conducive to proper control of hypothyroidism.''