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Synthroid Still Lacks Approval Necessary to Remain Legally on the Market After August 14, 2001 |
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FDA Says It Has No Plans to Extend Application Date
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Join the Discussion
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"I haven't experienced what I call high/low swings with Unithroid.
With Synthroid, it was strange, I would get heart palpitations one week and the next week I might feel really drained and tired...I'm convinced there's something wrong with the potency of Synthroid.
Also, I've had my Synthroid recalled in the past. This is why I'm very happy with Unithroid."
"Enter Your Quote Here"
CAROLMC1
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by Mary J. Shomon
As of February 15, 2001, the thyroid drug Synthroid still does not have the approved New Drug Application (NDA), needed in order to remain on the market after August 14th of this year, when the Food and Drug Administration (FDA) deadline for NDAs will make all unapproved levothyroxines illegal to sell. In order to remain legally available, Synthroid will either need to receive an approved NDA, or will have to successfully argue that this requirement should not apply to Synthroid and receive what is known as "Generally Recognized as Safe and Effective (GRAS/E)" status.
Synthroid(R), the #3 most prescribed drug in America, is also the most popular brand of levothyroxine hormone replacement on the market -- being taken by 85% of those using thyroid hormone drugs. It is estimated that 8 million people are currently being treated with levothyroxine products, the majority of them taking Synthroid.
To date, the only levothyroxine to receive approval is Unithroid(TM), a product of
Jerome Stevens Pharmaceuticals (and distributed by Watson Pharmaceucticals). Unithroid was approved by the FDA as safe and effective in August of 2000.
In a recent letter from the FDA's Association Commissioner for Regulatory Affairs, Dennis E.Baker, to representatives of Jerome Stevens Pharmaceuticals, the FDA has indicated: "At present, the August 14, 2001, deadline remains in place, and FDA has no plans to extend the date by which levothyroxine sodium products must have approved applications." (1)
Jerome Stevens has expanded its production capabilities in order to be in a position to meret the entire U.S. demand for levothyroxine, should no other products receive approvals in the next six months.
According to a press release issued by Watson:
Many are unaware that levothyroxine sodium has a long history of stability, potency, and consistency issues leading to recalls by the FDA. It is a notoriously unstable compound and difficult to produce. Since 1991, there have been at least 10 recalls of levothyroxine, involving 150 lots and 100 million tablets.(2) Issues ranged from the tablets having less active ingredient than indicated, to the failure of medication to maintain its potency through the expiration date. In addition, because levothyroxine sodium was available prior to the NDA approval process, it was not subject to the same strict regulations as FDA-approved drugs with New Drug Applications (NDAs). Therefore, manufacturers were able to reformulate the product, resulting in potency fluctuations of up to 30%.(2) The potential for these issues to negatively impact patients is vast. In addition, in a recent large- scale study, it was shown that approximately 40% of the participants who were on thyroid hormone had abnormal thyroid test results.
As a result of the problems stemming from levothyroxine sodium's inherent instability, the FDA issued a mandate in August 1997 requiring that all manufacturers of levothyroxine sodium have a complete and approved NDA filed by August 2000 to continue marketing.(2) At the request of Knoll Pharmaceutical Company, maker of Synthroid, the deadline was extended 1 year. Currently, the deadline is set at August 2001. After that, any levothyroxine sodium product without an NDA may be pulled from the market by the FDA.
To date, only the manufacturer of Unithroid has complied with the FDA mandate and received NDA approval. This means that there is only one levothyroxine sodium currently available that the FDA has approved as safe and effective, having satisfactorily addressed all issues regarding stability, potency, dissolution, and bioavailability. Watson Pharmaceuticals, Inc. has recently entered into an exclusive agreement with Jerome Stevens Pharmaceuticals to market Unithroid. Unithroid was previously produced under the names levothyroxine sodium and Thyrox(TM) for more than 10 years, with 1 billion tablets manufactured without a recall. Unithroid is now available by prescription only, and can be found at your local pharmacy. Patients with hypothyroidism should ask their physicians about their treatment options.
1. Letter from Dennis Baker, FDA, to Marc J. Schaineson, Esq.February 2, 2001
2. Department of Health and Human Services, Food and Drug Administration. Prescription drug products; levothyroxine sodium. Federal Register. 1997;62. Available at http://thyroid.about.com/blfdarpt.htm.
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