Groups Urge FDA Not to Recall Abbott Laboratories’ Synthroid
It’s always interesting to follow a heated debate over what many times appears to be an ineffectual therapy. I have seen many patients whose lab values came back to normal using synthetic hormone replacement, and yet clinically they still had all the signs and symptoms of hypothyroidism. The pharmaceuticals get rich and the patient doesn’t get any better. Thyroid glandulars, nutrients helping the conversion of thyroid hormone to its active form, and removing all sources of xenoestrogens can be a much more powerful approach to managing thyroid problems.
(article) In response to reports that the US Food and Drug Administration (FDA) might force Abbott Laboratories’ to recall Synthroid (levothyroxine), three professional and patient advocacy groups urged the agency on Monday to defer any action for the sakes of the millions of Americans on the thyroid drug. The American Thyroid Association, The Endocrine Society and Thyroid Cancer Survivor Association expressed concern that the removal will lead to the unnecessary discontinuation of these patients’ prescribed treatment. About two thirds of the 13 million Americans with hypothyroidism, thyroid cancer and other thyroid conditions are on this third most commonly prescribed drug in the US, the organizations noted. Therefore, “Even the threat of an interruption could cause alarm, inconvenience, and cost for patients who are doing well on their current thyroid medication,” said Dr. Paul Ladenson, secretary of the American Thyroid Association. Despite this appeal, the future of Synthroid remains uncertain. In April, the FDA told Abbott Laboratories that its thyroid medicine Synthroid has a “history of problems” and cannot be “generally recognized as safe and effective.” The FDA’s concerns were expressed in a letter, rejecting an Abbott petition to have the compound approved without the filing of a new drug application (NDA) detailing the drugs safety and effectiveness. Abbott, who acquired Synthroid’s maker earlier this year, is now expected to submit an application to the agency by the FDA’s August deadline. However, the FDA’s statements still raise the possibility that the popular 40-year-old drug could be removed from the market. The agency previously has refused to rule out asking for the drug’s withdrawal, saying it believes there are two other drugs in Synthroid’s class that could fill the void. Earlier this year, King Pharmaceuticals and Watson Pharmaceuticals secured FDA approval for similar products. But Abbott maintains that it is confident the drug will be allowed to stay on the market. The safety and efficacy of Synthroid has been extensively studied and validated, the company said in a prepared statement. The results of these studies have also been published in prominent peer-reviewed journals such as the New England Journal of Medicine, the drugmaker noted.