July 2002 -- On the heels of the June 2002 announcements of recalls, King Pharmaceuticals, manufacturer of Levoxyl, has announced further recalls of Levoxyl. The Levoxyl is being recalled because it lacks stability prior to its expiration dates. This recall affects almost 3 million tablets, in 50, 75, 88 and 100 microgram dosage sizes.
According to James E. Green, Senior Director of Corporate Affairs, this latest round of recalls, announced July 11, 2002 by the FDA, are for the old-formulation Levoxyl – Levoxyl that was made and distributed before the FDA approval. Recalls were also announced last month, in which 13,820 tablets in the 100 mcg size, and 18,600 tablets in the 50 mcg size, also old-formulation Levoxyl, according to Green.
When Levoxyl was approved by the FDA in May of 2001, it was a revised, quick-dissolving new formula that received approval, and the new product began shipping in August of 2001, usually carrying an 18-month expiration date.
According to Green, most of the recalled Levoxyl should not be in pharmacies or accessible to consumers. Some was held back in company warehouses, and some of it was donated to charities.
Old-formulation Levoxyl still remained in the pipelines, however, and continues to remain in the marketplace, which is the reason for the recalls. There is, therefore, a possibility that consumers may still be at risk of receiving some of this product when having a Levoxyl prescription filled, so patients taking Levoxyl should contact their pharmacies to double-check that they are not receiving Levoxyl from the recalled batches.
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A total of 2,885,015 units of Levoxyl distributed nationally and internationally are affected by the latest recall, and lots and recall #s include:
Last month's recall covered the following product:
- Levoxyl 50 mcg (0.05 mg), 100 and 1,000 tablet bottles, Recall # D-345-2.
- 50 mcg, 100 tablet bottle: Lot Nos. 6533, 6534, 6567, 6568, 6569, 6570 (exp 05/02)
- 50 mcg, 100 tablet bottle: Lot Nos. 6571 (Exp 06/02)
- 50 mcg, 100 tablet bottle: Lot Nos. 6623, 6624, 6626, 6627, 6628 (Exp 07/02)
- 50 mcg, 100 tablet bottle: Lot Nos. 6648, 6649, 6651, 6652, 6658, 6660 (Exp 08/02)
- 50 mcg, 100 tablet bottle: Lot Nos. 6732, 6736, 6737, 6738, 6740 (Exp. 10/02)
- 50 mcg, 100 tablet bottle: Lot Nos. 6771, 6772, 6795, 6796, 6797 (Exp 11/02)
- 50 mcg, 1000 tablet bottle: Lot Nos. 6572, 6573 (Exp 06/02)
- 50 mcg, 1000 tablet bottle: Lot Nos. 6650, 6659, 6661, 6662 (Exp 08/02)
- 50 mcg, 1000 tablet bottle: Lot Nos. 6733, 6735, (Exp 10/02)
- 50 mcg, 1000 tablet bottle: Lot Nos. 6773 (Exp 11/02)
- Levoxyl 75 mcg (0.075 mg), 100 and 1,000 tablet bottles, Recall # D-346-2;
- 75 mcg, 100 tablet bottle Lot Nos. 6542, 6543, 6574, 6576 (Exp 06/02)
- 75 mcg, 100 tablet bottle Lot Nos. 6633 (Exp 07/02)
- 75 mcg, 100 tablet bottle Lot Nos. 6634, 6635, 6636, 6637 (Exp 08/02)
- 75 mcg, 100 tablet bottle Lot Nos. 6694, 6695, 6696, 6698, 6699, 6701, 6702, 6703, (Exp 09/02)
- 75 mcg, 100 tablet bottle Lot Nos. 6753, 6754, 6755, 6756 (Exp 10/02)
- 75 mcg, 1000 tablet bottle Lot Nos. 6578 (Exp 07/02)
- 75 mcg, 1000 tablet bottle Lot Nos. 6638 (Exp 08/02)
- 75 mcg, 1000 tablet bottle Lot Nos. 6697, 6700 (Exp 09/02)
- 75 mcg, 1000 tablet bottle Lot Nos. 6807 (Exp 11/02)
- Levoxyl 88 mcg (0.088 mg), 100 and 1,000 tablet bottles, Recall # D-347-2;
- 88 mcg, 100 tablet bottle: Lot Nos. 6538, 6539, (Exp 05/02)
- 88 mcg, 100 tablet bottle: Lot Nos. 6593 (Exp 06/02)
- 88 mcg, 100 tablet bottle: Lot Nos. 6646 (Exp 07/02)
- 88 mcg, 100 tablet bottle: Lot Nos. 6668, 6669, 6670 (Exp 08/02)
- 88 mcg, 100 tablet bottle: Lot Nos. 6769, 6770, 6802, 6803 (Exp 11/02)
- 88 mcg, 1000 tablet bottle: Lot Nos. 6538 (Exp 05/02)
- 88 mcg, 1000 tablet bottle: Lot Nos. 6668 (Exp 08/02)
- 88 mcg, 1000 tablet bottle: Lot Nos. 6802 (Exp 11/02)
- Levoxyl 100 mcg (0.1 mg), 100 and 1,000 tablet bottles, Recall # D-348-2.
- 100 mcg, 100 tablet bottle: Lot Nos. 6555, 6556, 6557, 6562, 6563, 6564 (Exp 05/02)
- 100 mcg, 100 tablet bottle: Lot Nos. 6603, 6604, 6605, 6606 (Exp 06/02)
- 100 mcg, 100 tablet bottle: Lot Nos. 6645, 6716, 6718, 6722 (Exp 09/02)
- 100 mcg, 100 tablet bottle: Lot Nos. 6726, 6727, 6728, 6729 (Exp 10/02)
- 100 mcg, 100 tablet bottle: Lot Nos. 6764 (Exp 11/02)
- 100 mcg, 1000 tablet bottle: Lot Nos. 6613, 6614, 6615, 6616, 6617, 6618, 6631, 6632 (Exp 07/02)
- 100 mcg, 1000 tablet bottle: Lot Nos. 6642, 6643, 6644, 6717, 6719, 6723 (Exp 09/02)
- 100 mcg, 1000 tablet bottle: Lot Nos. 6724, 6725, 6761, 6762 (Exp 10/02)
- 100 mcg, 1000 tablet bottle: Lot Nos. 6763 (Exp 11/02).
- 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 Food and Drug Administration (FDA) approved for Levoxyl in late May of 2001, less than a year after the company submitted a new drug application for Levoxyl. 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.
What Should Patients Do?
If you take Levoxyl and suspect that you may have a batch of recalled Levoxyl, contact your pharmacist, and provide the following information:
If you are having problems on Levoxyl, here are some additional points to consider:
- Your prescription number, date filled, and quantity received
- Recall numbers and codes, so the pharmacy can check your prescription against the recalled product
- 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:
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.)