Will FDA Recall Synthroid?
June 3, 2001
A popular drug used by people suffering from hypothyroidism may be subject to Food & Drug Administration (FDA) regulatory action. Synthroid, manufactured by Abbott Laboratories, is a hormone replacement drug which has been on the market for over 40 years. However, after four decades, Synthroid has never applied for, nor received FDA approval.
Synthroid is the third most popular prescription medicine in the United States, and the drug has annual sales of over $540 million. However, the FDA reports, and Abbott Labs admits, that the drug's safety and efficacy have never been officially evaluated by the agency. Neither the FDA nor the company knows for certain why Synthroid was never subjected to the agency's approval process.
Levothyroxine sodium, the generic form of Synthroid, is produced by two competitors of Abbott. These competitors, King Pharmaceuticals and Watson Pharmaceuticals have applied for and won FDA approval of their versions of Synthroid. The FDA has given Synthroid's makers until August 14, 2001 to demonstrate that the Abbott drug is "safe and effective." According to the FDA, Synthroid has had a "history of problems" and cannot currently be considered "safe and effective." According to Abbott Labs, the company will submit an application explaining Synthroid's safety and efficacy prior to the August deadline.
Concern over Synthroid has increased over the last several years because of problems in the drug's manufacturing process and inconsistencies in the potency of the medication. The potency problems are particularly troubling as too little or too much of the drug may upset a patient's delicate hormonal balance.
According to sources close to the other levothyroxine sodium manufacturers, those competing companies are gearing up to produce more of the generic Synthroid should the real thing be pulled from the market in August.
The FDA had the following to say about Synthroid in a recent letter to Abbott Labs:
The drug has a history of potency problems which "indicate that Synthroid has not been reliably potent and stable." In addition, when "patients receive tablets that are filled with a product of unpredictable potency, therapy with levothyroxine sodium (Synthroid) is neither safe nor effective."
-- Article Courtesy of InjuryBoard.com
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