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Levoxyl's Reformulation: What You Need to Know
Fast-Dissolving Reformulation Causing Problems For Some Patients

by Mary J. Shomon

February, 2002 -- Many patients have written to me, asking about the differences they've noticed in their Levoxyl, the brand of levothyroxine made by King Pharmaceuticals.
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"I just called and complained to them about it cause I don't care for it myself. I did MUCH better on the old formulation than the new....I also informed them that there were others who were not doing well on the new formulation and that it was a shame because they might potentially lose people to other drugs."
Kris
Related Resources
• Levoxyl -- Frequently Asked Questions
• What is the Best Thyroid Drug
• Letters to Pharmacists Regarding Levoxyl's New Formulation
Elsewhere on the Web
• How to Decide on the Best Thyroid Drug for You
xPeople have reported that it dissolves quickly, and some patients have found that they have become more hypothyroid and required dosage adjustments.

I had an opportunity to find out some more details from King Pharmaceutical's Senior Director of Corporate Affairs, James Green, regarding the changes in Levoxyl.

The key issue is that Levoxyl, like the other levothyroxine products, was required to go through Food and Drug Administration (FDA) approval as a new drug. To date, Unithroid and Levoxyl have received FDA approval -- Synthroid and Levothroid have submitted applications but are awaiting approval. Levoxyl's approval came in May of 2001.

The formulation for Levoxyl submitted to the FDA for approval was different than the previous formulation, in order to ensure greater stability of the active ingredients. This addressed one of the chief complaints of the FDA, one that the new drug application process was meant to address. The reformulated Levoxyl is now lactose-free, and is also a quick dissolving formulation, unlike the previous formulation.

The quick dissolving formulation appears to be the change that has caused the greatest confusion and concern. According to Green, the company issued extensive information to pharmacists and doctors, indicating that patients should be counseled to take the drug with plenty of water, and to swallow it immediately. Green also said that the pharmacies had been asked that the drugs carry a label indicating that they should be taken with plenty of water.

Apparently, without enough water, there is a risk that the product will dissolve rapidly in the mouth, which could potentially interfere with a patient getting the proper dosage.

The new formula was being dispensed and distributed since August, but it wasn't until October, however, that communications were issued to pharmacies regarding the new formulation. Some patients who had larger supplies have only recently been getting refills, and getting the newly formulated product for the first time.

Some patients have reported that when picking up Levoxyl prescriptions filled since August, they have not received any counseling from pharmacists regarding these new instructions, nor are their bottles carrying labels saying to take the product with plenty of water.

Some patients, who refilled prescriptions in the past several months and got the new formulation -- but were not counselled regarding swallowing the product immediately with sufficient water -- are also now reporting that their TSH levels have risen and they have become hypothyroid.

Action Points

The key action points for thyroid patients who are taking reformulated Levoxyl:
  • Be sure to swallow the medicine immediately, with plenty of water, so that the Levoxyl does not dissolve on the tongue
  • If you have not been feeling well on the newly formulated Levoxyl, you should have your thyroid blood levels tested to make sure that you don't require a dosage adjustment, based on the new formulation
  • If you are taking your newly formulated Levoxyl properly, and still not feeling well, it might be time to investigate a competing brand of levothyroxine, or another thyroid drug. Read What is the Best Thyroid Drug


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