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ABBOTT
Dec 2001
Abbott is
aware of the news reports circulating today regarding Synthroid.
Abbott wants to reassure patients, physicians and pharmacists that
Synthroid is a safe and effective treatment for hyperthyroidism.
Abbott will be submitting a New Drug Application (NDA) in accordance
with FDA guidelines in order to ensure that the eight million
patients effectively treated with Synthroid have continued to access
to their medication. Abbott has notified the FDA of its intents
to submit its NDA and is working cooperatively with the agency to
meet the filling time frames.
Like some
other drugs that were marketed before 1962, Synthroid and all other
levothyroxine sodium products did not receive formal approval from
FDA, In 1997, FDA issued a Federal Register notice calling for
all manufactures of levothyroxine sodium products to either submit an
NDA, or to file a citizen petition to show that their products are
not new drugs, and therefore do not require a NDA. In
compliance with this notice, Knoll, the manufacturer of Synthroid at
the time, filed a citizen petition in 1997 requesting that FDA
acknowledge that Synthroid could be given a legal designation,
"generals recognized as safe and effective." (GRASE/E)
Abbott
obtained Synthroid on March 2, 2001, through its acquisition of BASF
Pharma/Knoll. On April 27, 2001 FDA informed Abbott that it
would not grant GRAS/E status for Synthroid under Knoll's citizen
petition. Abbott Laboratories promptly responded that it would
submit an NDA for Synthroid.
Synthroid is
the leading levothyroxine sodium product that has been trusted by
physicians and patients for 42 years. The safety and efficacy
of Synthroid has been extensively studied and validated. The
results of these studies have been published in prominent peer-review
journals such as New England Journal of Medicine. The place of
Synthroid in clinical practice is well established as a trusted
therapy by physicians, and by the more than eight million patients
with hypothyroidism depend on it every day.
"Synthroid
is a tried and trusted product with decades of use and physicians
and patients should continue to have confidence in Synthroid,"
Said Leonard Wartofsky, M.D., chairman, Department of Medicine,
Washington Hospital Center, Washington, D.C. "It would be
dangerous for patients if Synthroid were removed from the market."
Physicians and
patients should understand that FDA has not made a determination that
any levothyroxine sodium product, on the market with or without NDAs,
are interchangeable with another. Therefore, these products
have not been determined to be therapeutically equivalent by
FDA. The FDA publication Approved Drug Products with
Therapeutic Equivalence Evaluations, does not list any levothyroxine
sodium products as therapeutically interchangeable. Switching
from Synthroid to another levothyroxine sodium product would require
individual alteration by a physician.
As part of the
delicate endocrine system, the thyroid gland impacts essentially
every cell, tissue, and organ in the body. Guidelines several
endocrinology organizations, such as the American Association of
Clinical Endocrinologist (AACE), state that, once established,
thyroid patients should be maintained on the same brand of medication
throughout the treatment. If changes in the medication brand
are made, costly re-testing must occur to ensure proper dose
adjustment treatment.
Thyroid
hormones, either alone or together with other medications, should not
be used for the treatment of obesity, and should not be taken by
patients with untreated thyroticosis (excess of thyroid hormone),
uncorrected adrenal insufficiency, or apparent hypersensitivity to
thyroid hormones or any inactive product constituents. Adverse
events to Synthroid other that those related to thyrotoxicosis as a
result of overdose are rare: however, if a patient experiences
any unusual symptoms, he or she should consult with their health care provider.
Abbott
Laboratories is a global, diversified health care company devoted to
the discovery, development, manufacture, and marketing of
pharmaceuticals, nutritional, and medical products, including devices
and diagnostics. The company employs approximately 70,000
people and markets it products in more than 130 countries.
Abbott's news
release and other information are available on the company's web site at
http://www.abbott.com.
Responses
to Synthroid News Reports for Pharmacists
Q:
Will Synthroid remain available?
A:
Abbot will be submitting a New Drug Application (NDA) in accordance
with the FDA guidelines as part of its commitment to providing
continued access to Synthroid to the eight million patients who rely
on it everyday. Abbott has notified the FDA of its intent to
submit its NDA and is working cooperatively with the agency to meet
the filing timeframes.
Q:
Can I continue to fill Synthroid prescriptions?
A:
Synthroid continues to be available for patients. Abbott
Laboratories reminds you of Synthroid's long history of clinical use
in millions of patients. Abbott wants patients,
physicians and pharmacists to know that the clinical use of Synthroid
has been extensively studied. The results of these studies have
been published in prominent peer-reviewed journals such as the New
England Journal of Medicine. More than eight million patients
with hypothyroidism depend on Synthroid everyday.
Q:
What should pharmacists tell patients?
A:
Synthroid continues to be available for patients. Patients
should discuss this matter with their physician if they have other concerns.
Physicians and patients should understand that FDA has not
determined that any levothyroxine sodium product, on the market with
or without and NDA, in interchangeable with another. Therefore,
these products have not been determined to be therapeutically
equivalent by FDA. The FDA publication, Approved Drug Products
with Therapeutic Equivalence Evaluations (Orange Book), does not list
any levothyroxine sodium products as therapeutically interchangeable.
As part of the delicately-balanced endocrine system, the thyroid
gland impacts the entire body. Guidelines of several
endocrinology organizations, such as the American Association of
Clinical Endocrinologists (AACE), state that, once stabilized,
thyroid patients should be maintained on the same brand of medication
throughout treatment. Switching brands requires re-testing in
order to ensure proper dose adjustment.
Q:
Why doesn't Synthroid have FDA approval?
A:
Like some other drugs that were marketed before 1962, Synthroid and
all other levothyroxine sodium products did not receive formal
approval from FDA. In 1997, FDA issued a Federal Register
notice calling for all manufactures of levothyroxine sodium products
to either submit and NDA, or to file a citizen petition to show that
their products are not new drugs, and therefore do not require and
NDA. In compliance with this notice, Knoll, the manufacturer of
Synthroid at the time, filed a citizen petition in 1997 requesting
that FDA acknowledge that Synthroid could be given in a legal
designation, "generally recognized as safe and effective." (GRAS/E).
Abbott
obtained Synthroid on March 2, 2001, through its acquisition of BASF
Pharma/Knoll. On April 27, 2001 FDA informed Abbot that it
would not grant GRAS/E status for Synthroid under Knoll's citizen
petition. Abbot Laboratories promptly responded that it would
submit an NDA for Synthroid.
Clinical
Use and Safety Information
Synthroid is
used to treat hypothyroidism. Thyroid hormones, either alone or
together with other medicines, should not be used for the treatment
of obesity, and should not be taken by patients with untreated
thyrotoxlcosis (excess of thyroid hormone), uncorrected adrenal
insufficiency, or apparent hypersensitivity to thyroid hormones or
any inactive product constituents. Adverse events to Synthroid
other that those related to thyrotoxlcosis as a result of overdosage
are rare; however, if a patient experiences any unusual symptoms, he
or she should consult with their health care provider.
Please see
Synthroid Full Prescribing Information go to Abbott.com |
