Levoxyl Tablets Should Be Taken With Full Glass of Water, FDA Says

Yael Waknine

Disclosures

October 05, 2004

Oct. 5, 2004 -- The U.S. Food and Drug Administration (FDA) and Jones Pharma Inc. (a wholly owned subsidiary of King Pharmaceuticals) have warned healthcare professionals via letter of postmarketing reports of choking, gagging, tablets stuck in throat, and dysphagia associated with the ingestion of levothyroxine sodium tablets (Levoxyl), mainly when the tablets were not taken with water, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Levothyroxine is indicated in the treatment of hypothyroidism.

According to the letter, these symptoms are caused by the rapid swelling and disintegration of tablets upon ingestion. The FDA recommends that levothyroxine tablets be taken with a full glass of water.

More information may be obtained by contacting Jones Pharma Product Information at 1-800-776-3637. Adverse events associated with the use of levothyroxine tablets may be reported to Jones Pharma at 1-800-546-4905.

Adverse events may also be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch/index.html, or by mailing form FDA 3500 to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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