Levoxyl Returns to the Market

After being off the marked for over a year, the branded medication Levoxyl (levothyroxine sodium) is expected to be available in pharmacies on approximately March 3, 2014, according to a statement released by Pfizer. The medication is approved to treat hypothyroidism and various types of euthyroid goiters.
Pharmacy background, focus on person typing on cash register“We are pleased to learn that this week Pfizer will have available in retail pharmacies in the U.S. Levoxyl,” said Hossein Gharib, MD, MACP, MACE, President of the American Thyroid Association, Professor of Medicine at the Mayo Clinic College of Medicine in Rochester, Minnesota, and Past President of the American Association of Clinical Endocrinologists.

“Many patients were disappointed when the drug was voluntarily withdrawn from the market in early 2013 because of an odor in some samples. The cause has been identified and the problem corrected,” Dr. Gharib said.

The Reason for the Recall
Levoxyl was recalled on February 13, 2013 after reports from patients and pharmacists of an odor that was released from bottles a few days after they were opened. Pfizer determined that the source of the odor was an oxygen-absorbing canister that was packaged with some of the bottles. While the odor was not likely to cause any adverse events, the company decided to voluntarily recall the medication “out of an abundance of caution,” according to Pfizer.

Pfizer corrected the problem with the canister and has resumed manufacturing of Levoxyl.

Which Patients Should Receive Levoxyl?
“I believe that Levoxyl was pulled from the market more out of caution than any concern over the medication itself,” commented Bryan R. Haugen, MD, Past President of the American Thyroid Association as well as Professor of Medicine and Pathology, and Head of the Division of Endocrinology, Metabolism, and Diabetes at the University of Colorado School of Medicine in Aurora, Colorado.

“Levoxyl will come back in as a branded product and I primarily see physicians considering it for patients who have previously done well on Levoxyl or those being considered for branded levothyroxine,” Dr. Haugen said. “As we recommend for any patients switched on levothyroxine products, patients who are put back on Levoxyl from another levothyroxine product, should have a serum thyroid-stimulating hormone levels measured approximately 6 weeks after the switch,” he said.

 

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