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Warning Regarding Levoxyl

FDA and Manufacturer Say Product Must Be Taken With Water

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Updated October 07, 2004

Updated October 07, 2004
U.S. Food and Drug Administration and Jones Pharma Inc. (the subsidiary of King Pharmaceuticals that makes the thyroid drug Levoxyl) have issued a warning letter to healthcare providers, indicating that there are reports of patients having choking, gagging, tablets stuck in the throat, and difficulty swallowing after when taking Levoxyl brand levothyroxine, primarily without water. Levoxyl is the second most popular brand of thyroid hormone replacement, behind Synthroid.

According to the manufacturer, the tablets may quickly swell and disintegrate, which may cause them to become stuck in the throat if taken without water, or without sufficient water.

According to MedWatch, the FDA's safety information and adverse event reporting program, the FDA and Jones have notified healthcare professionals of revisions to the "PRECAUTIONS, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections of labeling, describing reports of choking, gagging, tablets stuck in throat and dysphagia while taking Levoxyl. These reports have predominantly occurred when Levoxyl tablets were not taken with water. It is recommended that Levoxyl tablets be taken with a full glass of water."

You can read the complete FDA letter to practitioners now. (You may also want to print out the PDF version and share it with your pharmacist and doctor, to help spread the word). Also, see the new Levoxyl drug insert (PDF format).

If you have any questions or concerns regarding this safety information, please contact Jones Pharma Product Information at 1-800-776-3637. Forward any adverse event information associated with the use of Levoxyl® to Jones Pharma at 1-800-546-4905. You can also find out more about Levoxyl at the product website www.levoxyl.com.

NOTE: The advisory to take the reformulated Levoxyl with a full glass of water was made here at the About Thyroid site after I interviewed officials at the manufacturer back in February of 2002. For complete information, read Levoxyl's Reformulation: What You Need to Know.

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