Guest NewsItem Posted July 20, 2001 Report Share Posted July 20, 2001 <P ALIGN="center"><B>Abbott Laboratories Gratified by Court's Decision Granting Preliminary Injunction Against Watson Pharmaceuticals' False Advertising Against Synthroid</B></P> Decision to End False Advertising, Deceptive Trade Practices About Synthroid® (Levothyroxine Sodium, USP) 'Welcome News For Thyroid Patients' ABBOTT PARK, Ill., July 20 /PRNewswire/ -- In response to news media inquiries seeking comment by Abbott Laboratories about today's decision by the U.S. District Court for the Northern District of Illinois, in Chicago, Abbott issued the following statement: Abbott Laboratories is gratified that the court has acted to ensure patient safety by granting its request to issue a preliminary injunction prohibiting the false advertising and deceptive trade practices of Watson Pharmaceuticals regarding Abbott's prescription thyroid drug, Synthroid® (Levothyroxine Sodium, USP). "We are pleased with the court's action as it protects the more than eight million patients who depend on Synthroid every day to successfully treat their thyroid disease," said David Pizzuti, M.D., vice president of Global Medical Affairs at Abbott. "Healthcare professionals have been inundated by alarming, medically inaccurate information from Watson Pharmaceuticals, and subjected to a campaign of fear, concern and confusion. This campaign deliberately misrepresented the regulatory process governing prescription drugs, as the court has affirmed." The court prohibited Watson from continuing to mislead physicians and patients and found that Watson was making the following misrepresentations: 1) The manufacturer of Synthroid violated the U.S. Food and Drug Administration's (FDA) August 1997 notice by failing to file a New Drug Application (NDA) for Synthroid; 2) That Synthroid is not safe and effective and that the FDA's denial of the petition seeking "generally recognized as safe and effective" status (GRAS/E) for Synthroid demonstrates that Synthroid is not safe and effective; 3) That the FDA's approval of the NDA for the Watson levothyroxine drug, Unithroid, means that it is a superior product to Synthroid and other levothyroxine products that have not yet received NDA approval. In making its decision, the court noted concern for the public interest. Specifically the ruling states, "The public certainly is entitled to truthful advertising. And this consideration is especially weighty in this case because of the risks involved in patients unnecessarily switching drugs as a result of false advertising." In fact, the American Association of Clinical Endocrinologists (AACE) explained in a public statement issued June 1, 2001: "AACE is greatly concerned that the precipitous removal of Synthroid would create a massive and expensive burden for both patients and physicians alike. Synthroid patients would have to visit physicians for an alternative medication. This would require a significant change in pharmacy orders. Moreover, patients will be confused and unnecessarily alarmed over the safety of the drug." As previously stated, Abbott will submit an NDA for Synthroid in advance of the FDA's required submission date of August 14, 2001, and is confident that the NDA will demonstrate safety and efficacy and will be approved. In its guidance issued on July 12, the FDA provided assurance that Synthroid will remain on the market subject to a gradual phase down of distribution while the agency reviews the NDA Abbott will be submitting for this product. Patients can be assured of a continued adequate supply of Synthroid while the FDA reviews the NDA for this product. There is a large supply of Synthroid currently available on the market and Abbott will continue to manufacture and ship Synthroid in accordance with the Guidance while the NDA is under review. Major medical societies and patient-focused organizations -- including AACE, the American Thyroid Association, the Thyroid Foundation of America and the Thyroid Cancer Survivors' Association -- have publicly stated support for keeping Synthroid available for the millions of patients who are currently well controlled on the medication. The guidelines of several of the leading endocrinology associations recommend that patients remain on their brand of levothyroxine sodium if they are well controlled; if their medication is switched, patients must be reevaluated and retested. Otherwise, the health of patients may be at risk. Switching prescription thyroid drugs is not as simple as merely matching dosage. Synthroid has been used for more than 42 years and is the third most prescribed drug in the United States. Eight million patients take Synthroid every day to treat their thyroid disease. Thyroid hormones, either alone or together with other medicines, should not be used for the treatment of obesity, and should not be taken by patients with untreated thyrotoxicosis (excess of thyroid hormone), uncorrected adrenal insufficiency, or apparent hypersensitivity to thyroid hormones or any inactive product constituents. Adverse events to Synthroid other than those related to thyrotoxicosis as a result of overdosage are rare; however, if a patient experiences any unusual symptoms, he or she should consult with their health care provider. Further information about this issue is available at Abbott's Web site, www.synthroid.com , or by calling Abbott at 1-800-255-5162. Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. Quote Link to comment Share on other sites More sharing options...
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