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Senior Alert
Seniors Should Report Adverse Medical Reactions to
FDA’s MedWatch
FDA also has special online sites just for senior
citizens
 Jan.
20, 2006 - The FDA MedWatch program is designed to identify serious
reactions and problems with medical devices and other medical products
and it needs information from the public on adverse medical reactions to
provide proper information. The MedWatch Website is the place to report
problems or to get the latest information on medical product problems
identified by FDA. The agency, however, has other sites that are
specifically for senior citizens.
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Senior Alerts |
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These "other medical products" include medicines
(prescriptions and over the counter), blood products, and special
nutritional products (dietary supplements, infant formulas, and medical
foods).
FDA designed this program to ensure that new safety
information is quickly communicated to medical professionals. One of the
program's aims is to monitor medical products once they are used in
clinical practice.
A reaction is considered serious if a medical
product caused or is suspected of having caused at least one of the
following:
● death
● life-threatening situation
● admission to a hospital
● longer-than-expected hospital stay
● permanent disability
● a birth defect
● medical care to prevent permanent damage
If you or a family member have experienced or
witnessed a serious adverse reaction or other problem with any FDA
regulated product, call MedWatch at 1-800-FDA-1088 (1-800-332-1088) to
request a one-page reporting form. Your return postage will be paid.
Forms and instructions can also be downloaded from
http://www.fda.gov/medwatch/.
FDA encourages seniors and other consumers to take
the form to their health professional (doctor, dentist, pharmacist, or
nurse) to complete. The health professional can voluntarily provide more
detailed clinical information, such as laboratory results, that can help
FDA evaluate the report.
However, if you prefer, you can complete the form
yourself and mail it to the FDA address on the form or FAX it to
1-800-FDA-0178 (1-800-332-0178). You are encouraged to file a report,
even if your health professional chooses will not.
You will receive an acknowledgement from FDA after
your report is received. You will be personally contacted only if FDA
needs additional information.
For information about a medical product, please
call the FDA's toll-free information line at 1-888-INFO-FDA
(1-888-463-6332). Follow the directions to select the medical product
you are interested in.
Special Information for Senior Citizens
The FDA also maintains a Website just for senior
citizens -
www.fda.gov/oc/seniors/.
FDA Information for Seniors has numerous articles,
brochures and other publications with information for older people on a
wide range of health issues, including arthritis, cancer, health fraud,
and nutrition. Selected publications are also in Spanish.
Last year, the agency also introduced a new Website
on senior citizen health matters, named Maturity Health Matters. The
first information was loaded in November but no additional information
has been published. The site is at
www.fda.gov/cdrh/maturityhealthmatters/.
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