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For over 42 years, Synthroid has been extensively studied. It is the most prescribed thyroid medication in the United States, and is currently available at 99 percent of pharmacies nationwide. Today, over eight million people rely on Synthroid for thyroid replacement therapy.
Synthroid is taken by patients who have hypothyroidism or other disorders of the thyroid. Tyroid 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.
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Disclaimer: This website is dedicated to providing public information regarding automobile accidents in Nevada, dangerous drug injuries, big-rig accidents, auto accidents, motorcycle accidents, personal injury, wrongful death, dog bites, nursing home negligence, insurance bad faith, product liability, amusement park accidents, toxic chemical deaths, slip and fall injuries and other legal information. None of the information on this site is intended to be formal legal advice nor the formation of a lawyer or attorney client relationship. Please contact a personal injury lawyer for information regarding your particular case. This does not guarantee, warranty or predict the outcome of your case, results are from NV & CA and include independent associated counsel. Dwight Sper is a paid spokesman for Robert Koenig. Last, please be advised that Lawyers’ Group of Nevada, Inc. is not affiliated with any public agency, the advertisements that recite results or monies collected do not constitute a guaranty, warranty or prediction regarding the outcome of your case, and said results include the efforts of Independent Associate Counsel from the states of NV and CA. In addition, the person’s depicted in the advertisements are for ad purposes only and may not be members of the firm. They are for illustrative purposes only.
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