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Levoxyl recalled, may be unavailable until 2014

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The American Thyroid Association has acknowledged a recall of levothyroxine sodium, according to a statement on their website. The drug may not be available until 2014.

“We have this morning received additional information from Pfizer regarding the unavailability of levoxyl that was initially communicated last week,” the acknowledgment said.

The ATA has asked health care providers to consider the shortage in their practice patterns and plan for managing patients that are currently taking levothyroxine sodium (Levoxyl, Pfizer).

Last week, the ATA and drug manufacturer reported in a letter to health care providers and pharmacists that the manufacturer had halted shipping all strengths of the product as of February 13, 2013 and the backorder situation was currently being discussed with the FDA.

According to the latest letter to health care providers from King Pharmaceuticals LLC, a subsidiary of Pfizer Inc., a recall of levothyroxine sodium has begun at retail pharmacies due to complaints from pharmacists and patients of an “uncharacteristic odor” following the opening of some bottles.

“The odor is related to the oxygen-absorbing canister that is packaged in the 100-count and 1,000-count bottles. Pfizer has conducted a careful health assessment and has concluded that the odor is not likely to cause any adverse health consequences. However, the company discussed this situation with the FDA and decided, out of an abundance of caution, to voluntarily recall all strengths of Levoxyl to the retail level. There is no need for patients to return or discard the medication they have, as they may continue to take the medication in accordance with their health care provider’s prescribed directions,” the manufacturer wrote.

Pfizer has announced that a change in therapy is at the physician’s discretion and that they are working to resolve the issue. However, the manufacturer said the drug may not be available until 2014.

In addition to the recall, Pfizer wrote that free-trial vouchers are also unavailable due to the lack of product supply. Clinicians are advised not to distribute free-trial vouchers to their patients. Health care providers and pharmacists are advised to call 1-800-438-1985 for medically-related questions about the drug.

For more information:

American Thyroid Association announcement. Accessed April 1, 2013.

Pfizer Recall Letter. Accessed April 1, 2013.