Page 13 - Senior Times South Central Michigan - December 2018 - 25-12

UNDERSTANDING UNAPPROVED USE OF APPROVED DRUGS
"OFF LABEL"
Has your healthcare provider ever talked to you about using an FDA- approved drug for an unapproved use (sometimes called an “off-label” use) to treat your disease or medical condition?
It is important to know that before a drug can be approved, a company must submit clinical data and other informa- tion to FDA for review. The company must show that the drug is safe and effective for its intended uses.
“Safe” does not mean that the drug has no side effects. Instead, it means the FDA has determined the benefits of using the drug for a partic- ular use outweigh the potential risks.
When you are prescribed a drug for its approved use, you can be sure:
• That FDA has conducted a careful
evaluation of its benefits and risks for
that use.
• The decision to use the drug is sup-
ported by strong scientific data.
• There is approved drug labeling for
healthcare providers on how to use the
drug safely and effectively for that use.
• The approved drug labeling for health-
care providers gives key information
about the drug that includes:
• The specific diseases and conditions
that the drug is approved to treat.
• How to use the drug to treat those specific diseases and conditions.
• Information about the risks of the
drug.
• Information that healthcare providers
should discuss with patients before they take a drug.
Some drugs may also have label- ing information for patients such as Medication Guides, Patient Package Inserts, and Instructions for Use.
Why might an approved drug be used for an unapproved use? From the FDA perspective, once the FDA approves
a drug, healthcare providers generally may prescribe the drug for an unap- proved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want
to prescribe a drug to treat a disease
or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all
approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.
What are examples of unapproved uses of approved drugs? Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is:
• Used for a disease or medical con-
dition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer.
• Given in a different way, such as when a drug is approved as a capsule, but it is given instead in an oral solution.
• Given in a different dose, such as when a drug is approved at a dose of one tablet every day, but a patient is told by their healthcare provider to take two tablets every day.
If you and your healthcare provider decide to use an approved drug for an unapproved use to treat your disease or medical condition, remember that FDA has not determined that the drug is safe and effective for the unapproved use.
If your healthcare provider is think- ing about using an approved drug for an unapproved use, you may want to ask your healthcare provider questions like these:
• What is the drug approved for?
• Are there other drugs or therapies that
are approved to treat my disease or
medical condition?
• What scientific studies are available to
support the use of this drug to treat my
disease or medical condition?
• Is it likely that this drug will work
better to treat my disease or medical condition than using an approved treatment?
• What are the potential benefits and risks of treating my disease or medical condition with this drug?
• Will my health insurance cover treat- ment of my disease or medical condi- tion with this drug?
• Are there any clinical trials studying the use of this drug for my disease or medical condition that I could enroll in?
Food and Drug Administration’s (FDA) For Patients page is the source for this article with the full article and the latest updates on FDA regulated products available at https://www.fda. gov.
That was one of your best decisions.
From
Senior Times - December 2018
Page 13
THE PHARMACY
Rose Baran, PharmD, Special to Senior Times
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Laurels of Bedford
Honors Veterans
By: Sally Goss
Laurels of Bedford took time out on November 12 to recognize the Veterans who are residents at their building.
The Honorable Mayor of Battle Creek, Mark Behnke, was present to give his
regards as well. These men have given time out of their lives to serve their country and preserve our freedom. We are grateful for their service to the United States of America.
Legal Advice &
Services for Seniors
By: Karen Braasch
The Legal Services of South Central Michigan-Battle Creek office will conduct interviews for legal advice and possible representation, without charge, to interested seniors.
Wednesday, Dec 5, 10am-12:30pm, Burnside Senior Center, 65 Grahl, Coldwater, MI, 49036.
For more information reach out to Alisa Parker, Managing Attorney, at (269) 965- 3951. The Calhoun / Branch / Barry Office is located at 123 West Territorial Road, Battle Creek, MI, 49015.