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Thyroid Patient Advocacy Group Warns Thyroid Patients of
Potential Problems With Thyroid Drug Resulting From FDA Approval
of Generic Versions
TFA is a member of the Alliance for Thyroid Patient
Education
July 13, 2004
(FALLS CHURCH, VA) – The ATA Alliance for Thyroid Patient
Education, an organization of leading patient education and advocacy
groups, recommends that patients being treated with levothyroxine
— a drug used to treat hypothyroidism, or an underactive thyroid
— not make any changes in their brand of medication without
first discussing the benefits, risks, and outcomes with their doctors.
This recommendation follows a recent decision by the Food and Drug
Administration (FDA) to approve generic levothyroxine preparations
as equivalent to branded preparations. The FDA ruling means that
generic levothyroxine products are now deemed to be equivalent in
treatment outcome and safety profile as the branded product. When
drugs are considered therapeutic equivalents, pharmacists can change
a prescription from one brand to another, often without the patient
or physician being aware of the change.
Levothyroxine is a drug recognized to have a narrow toxic to therapeutic
ratio with significant clinical consequences of excessive or inadequate
treatment. There are 12 tablet strengths of levothyroxine available
that vary by as little as 9 percent in drug content, reflecting
the close titration that is required for optimal patient management.
Thirteen million Americans are on levothyroxine products and those
especially susceptible to incorrect titration include the elderly,
pregnant women and their developing fetuses, and those with thyroid
cancer.
“Even though having access to generic drugs can result in
lower drug costs for patients, ensuring safety and effectiveness
should always be the number one priority when providing generic
alternatives,” said Alan P. Farwell, MD, Alliance Chair, Associate
Professor of Medicine at the University of Massachusetts Medical
School, and a staff physician at UMassMemorial Health Care. “In
this case, serious questions have repeatedly been raised about the
methodology used by the FDA to determine bioequivalence between
branded and generic levothyroxine preparations, which can result
in dangerous health problems in some individuals.”
Despite assurances to the endocrinology medical community that
the concerns regarding the limitations in current levothyroxine
bioequivalence standards would be addressed before ruling on generic
levothyroxine approval, the FDA made its decision without input
from clinical endocrinologists, the recognized experts in this area
and those who care for thyroid patients.
As a result of the FDA decision, the ATA Alliance is providing
guidance for patients through a statement posted on the ATA web
site, www.thyroid.org, including recommendations that patients to
take charge of their health by:
- Knowing which brand of levothyroxine that their doctor prescribes
and asking to stay that brand;
- Being aware that pharmacists may change their brand when a
prescription is filled and, therefore, checking prescription before
leaving the pharmacy;
- Asking their doctors to check their thyroid-stimulating hormone
(TSH) levels in four to six weeks to determine if dose retitration
is needed, in the case of a change in the brand of levothyroxine.
“We cannot emphasize enough the importance of staying on
the medication that is specifically prescribed for Graves’
Disease patients,” said Nancy Patterson, of The National Graves’
Disease Foundation. “To change medications, especially without
medical supervision, can be dangerous. The careful monitoring of
one’s thyroid status is vital to maintaining optimal health.”
Joan Shey, President and Founder of the Light of Life Foundation,
a group that focuses on thyroid cancer, also commented that “Thyroid
health is a partnership between the patient and doctor. Patients
should always check their prescription to be sure that it is filled
by the pharmacy as the doctor wrote it. The bioequivalency level
has to be exactly the same from prescription to prescription because
the synthetic hormone is used to suppress any residual microscopic
tumor that may be left behind.” She added, “TSH levels
are maintained at a level optimal for controlling the cancer, balanced
with the need for thyroid hormone due to surgical removal of the
thyroid gland.”
The ATA Alliance for Thyroid Patient Education, an organization
supported by the American Thyroid Association, is composed of the
following thyroid patient education and advocacy groups: Thyroid
Foundation of America, ThyCa: Thyroid Cancer Survivors Association,
National Graves’ Disease Foundation, and the Light of Life
Foundation. The mission of the ATA Alliance is to standardize and
validate information provided to patients about the diagnosis, evaluation
and treatment of thyroid diseases, based upon evidence-based, unbiased,
non-anecdotal, accurate data and provided for the patient’s
best interest. The ATA Alliance supports patient education and public
awareness of thyroid disease.
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