On June 1st, 20001, the Wall Street Journal reported that the Food and Drug Administration has told Abbott Laboratories the maker of Synthroid, one of the nation's most frequently prescribed drugs, that the medicine has a "history of problems" and can not be recognized as "safe and effective.

Synthroid is taken by patients who have hypothyroidism or other disorders of the thyroid. Thyroid replacement therapy usually continues throughout the patient's lifetime. The agency's statements raise the possibility that the 40-year-old drug, which has never been officially approved for use by the FDA, will be subject to regulatory action that could possibly remove the drug from the market.

Patients using Synthroid should be monitored with regular blood tests to assess the effect the medication is having on thyroid function and also to check for toxicity. Too much Synthroid can cause a condition known as "thyroid storm". Patients might experience heart rate irregularities. Clots can be dislodged, and, in some cases, may help lead to stroke. At worst, a general hyperactive metabolic state can even lead to death.

The FDA has indicated that Synthroid needed to be approved by August 14, 2001, but as of June 1,2001, Abbott has indicated that they have not even applied for approval. The FDA stated they wouldn't rule out asking for the drug's removal and noted that there are two other approved drugs in Synthroid's class that could potentially fill any void left by Synthroid..

Synthroid had sales of $541.3 million in 2000 and, ranked by number of prescriptions written, was the third most frequently prescribed drug in the country, according to data compiled by IMS Health.

Synthroid went on the market more than four decades ago and never received formal approval from the FDA. According to the Wall Street Journal, such approval was required but neither the agency nor the drug's current owner is certain why it was never received.

In the mid-1990s, the FDA began compiling data on adverse events associated with the use of Synthroid as well as with the use of its competitors. In 1997, it noted that "almost every manufacturer" of such drugs had reported recalls because of potency problems.

We bring this important information to your attention to better educate you about the risks and dangers of prescription and pharmaceutical drugs.
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