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Levoxyl Recalls and Quality Questions
While Stock Price Goes Up and Sales Increase, Concerns Rise

from Mary Shomon

June 2002 -- King Pharmaceuticals, manufacturer of Levoxyl, saw sales of its levothyroxine drug Levoxyl climb 130% to $39.8 million in 2001. The sales increase was likely a result of obtaining FDA approval before market leader Synthroid, which did not apply for FDA approval until fall of 2001, and remained unapproved throughout the remainder of the year. It's also likely that negative publicity surrounding controversies over Synthroid may have allowed Levoxyl to siphon off additional market share.

King is an incredibly profitable company, which according to stock experts is keeping net income levels at a very high rate -- 26.7% of sales -- versus an S&P 500 average of just 5.3%.) In early June of 2002, SmartMoney named the Company as No. 1 on its list of "Lean, Mean, Future Profit Machines."

King received Food and Drug Administration (FDA) approval for Levoxyl in late May of 2001, less than a year after its submission of a new drug application. Per an FDA requirement issued in 1997, all levothyroxine drugs were required to go through FDA approval as a new drug. To date, Unithroid, Levoxyl and Levo-T have received FDA approval -- Synthroid and Levothroid have submitted applications but are still awaiting approval as of June, 2002.

Levoxyl was reformulated, and the reformulated version submitted for FDA approval. The reformulated version is now the version of Levoxyl currently available on the market, and is substantially different from the previous formulation.

Since the reformulation, patients have been reporting that they are having problems with the differences in the new formulation, finding that it dissolves too quickly. Some patients have found that they have become more hypothyroid and required dosage adjustments after switching from another levothyroxine to Levoxyl, or after using up their stock of older Levoxyl and receiving a batch from the new formulation.

In February of 2002, I spoke with King Pharmaceutical's Senior Director of Corporate Affairs, James Green, regarding these changes in Levoxyl.

According to Green, the formulation for Levoxyl submitted to the FDA for approval differed from the previous formulation, and provides ensure greater stability of the active ingredients. Stability was one of the chief complaints of the FDA that led to the overall new drug application process in the first place. In addition to stated improvements in stability, the reformulated Levoxyl is also now lactose-free, and is a quick dissolving formulation, unlike the previous formulation.

Initially, 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 of 2001, but it wasn't until October of 2001 that communications were issued to pharmacies regarding the new formulation. And some patients who had larger supplies of Levoxyl in stock have only recently been getting refills, and are therefore receiving the newly formulated Levoxyl for the first time.

Some patients have reported that when picking up Levoxyl prescriptions filled since August of last year, 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. Many patients also state that they are not receiving any patient literature explaining the new formulation.

Some patients, who refilled prescriptions 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, apparently as a result of not properly taking the quick-dissolving formulation.

However, in addition to patient problems with the quick-dissolving aspect, the remaining stock of old Levoxyl has caused stability problems for patients, with a June 2002 nationwide recall on Levoxyl. The FDA recently announced the nationwide recall of 13,820 tablets in the 100 mcg size, and 18,600 tablets in the 50 mcg size. According to the FDA, these batches of Levoxyl -- which according to King spokesperson James Green are from among the few remaining stocks of the old version of Levoxyl -- lack stability prior to their expiration dates, and exhibit either subpotency or super potency -- meaning that they are either not strong enough, or too strong, based on their stated dosage.

Are You Taking Recalled Levoxyl?

According to King's James Green, speaking in June of 2002, when the new formulation began distribution, some of the old formulation Levoxyl was not distributed, and what was still in the pipeline should for the most part have been used up by now. Some of the recalled Levoxyl was also from batches that were never distributed in the first place.

However, given that there still is some of the old formulation Levoxyl, there is still a small chance that you may have a prescription filled with old formulation recalled Levoxyl.

If you take Levoxyl in 50 or 100 mcg size pills and suspect that you may have a batch of subpotent or super potent Levoxyl, contact your pharmacist, and provide the following information:

  • Your prescription number, date filled, and quantity received
  • Recall Numbers and Codes
    • Levoxyl Tablets, 50 mcg, Each tablet contains Levothyroxine Sodium 50 mcg, 100 tablet bottles, Rx only. Recall # D-287-2 / 1270232, 1274149, 1275252, 1278114, 1282197, Product code, 5300-0.
    • Levoxyl Tablets, 100 mcg, Each tablet contains Levothyroxine Sodium 100 mcg, 30 and 100 tablet bottles, Rx only, Recall # D-288-2. / 100 mcg, 30 tablet bottles -- 1243074, 1249173, 1250073, 1270231, 1275251, 1283185, 1297190, Product code 5297-0, 100 mcg, 100 tablet bottles -- 1229122, 1234214, 1243125, 1253084, 1274147, Product code 5297-1
  • The recalling firm: Allscripts Healthcare Solutions of Libertyville, IL, which was distributing the Levoxyl, manufactured by King Pharmaceuticals, Inc. (formerly Daniels Pharmaceuticals)
In October of 2001, King issued another nationwide recall on more than 55,000 units of Levoxyl 25 mcg, in 100 and 1000 tablet bottles. In that recall, the reason was subpotency -- the product was not as strong as the stated dosage. Those tablets -- also from the old formulation -- carried expiration dates of November and December 2001.

What Should Patients Do?

The key action points for thyroid patients who are taking 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 Levoxyl, you should check with your pharmacist to make sure that you are not taking a batch that is part of the various Levoxyl recalls.
  • 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 entirely. Read What is the Best Thyroid Drug?
PATIENT TIP ON LEVOXYL!


If you have to take Levoxyl, and have no other options, but are finding that it dissolves too quickly, or you are not getting the full benefit of the drug, talk to your doctor or pharmacist about the possibility of getting a prescription for gelatin capsules to put your Levoxyl pills inside of before taking them. Some patients have reported that this has helped. Here's one patient letter:

Dear Mary:

I have appreciated the info on your website about the various thyroid drugs and I thought I would share a helpful tip. I just had I-131 treatment in September and had an allergic reaction to Synthroid. I then went on Armour, but it wasn't enough. I was then put on Levoxyl but it made me desperately ill: terrible acid reflux and stomach pain, but my other symptoms seemed much better. I contacted a friend who is a pharmacist about the problem. He confirmed what your website said about the quick dissolving problem. He said drink MORE WATER, which I did, but it didn't help. He then suggested that I get a prescription for gelatin capsules and place the pills inside. They fit perfectly inside larger capsules and Voila! the symptoms DISAPPEARED completely. I went from taking Prilosec twice daily with continuing symptoms to no symptoms at all. Now I'm on a combination of Levoxyl and 1/2 of a Cytomel, and I just stick them all in a capsule, making them up a month at a time. It's easy and cheap, and has saved me incredible suffering (not to mention the cost of the Prilosec.)



Sticking Out Our Necks and this website are Copyright Mary Shomon, 1997-2003. All rights reserved. Mary Shomon, Editor/Webmaster
All information is intended for your general knowledge only and is not a substitute for medical advice or treatment for specific medical conditions. You should seek prompt medical care for any specific health issues and consult your physician or health practitioner before starting a new treatment program. Please see our full disclaimer.