[Host] We’ve reviewed how dietary supplements are defined, regulated, and labeled, and what
types of claims are permitted.
Now let’s discuss potential interactions, adverse events, and
how to report them to FDA.
[On-screen] Dietary Supplement Interactions
[Host] FDA strongly encourages you to talk to your patients about the
dietary supplements they are taking.
This is important for many reasons.
First, dietary supplements can interact with drugs that you prescribe or
recommend to your patients.
Certain dietary supplements can alter the absorption, metabolism, or excretion of a
medication, which can affect its potency.
As a result, combining dietary supplements with certain prescription and over-the-counter
medications could have dangerous, and even life-threatening consequences.
For example, the herbal supplement, St. John’s wort, can reduce the efficacy of some medications
for heart disease, cancer, HIV, depression, seizures, and birth control.
Certain supplements can also interact with the anticoagulant Warfarin, including vitamin
K, high doses of vitamin E, and ginkgo biloba and others, such as vitamin C and Vitamin
E, might reduce the effectiveness of some types of cancer chemotherapy.
Secondly, some dietary supplements can interfere with laboratory tests, causing incorrect test
results which may go undetected.
Healthcare professionals should ask what dietary supplements their patients are taking when
considering lab work as a diagnostic tool.
For example, biotin is a water-soluble vitamin often found in multivitamins, prenatal vitamins,
and dietary supplements marketed for hair, skin, and nail growth.
FDA is particularly concerned about biotin interference causing a falsely low result
for troponin, a clinically important biomarker that helps with diagnosing heart attacks.
An inaccurate result could lead to a missed diagnosis and
potentially serious clinical implications.
While biotin is just one example, it is possible that other dietary supplements could also
interfere with diagnostic tests.
If a lab test result does not match the clinical presentation of your patient, consider supplement
interference as a possible source of error; and communicate with the lab conducting the
testing if you suspect supplement interference.
It is also important to notify the lab test manufacturer and FDA if you become aware of
a patient experiencing an adverse event following a potentially incorrect laboratory test result
due to dietary supplement interference.
In addition to potential drug and laboratory test interactions, it is important to advise
your patients that taking too much of certain supplements can have detrimental health effects.
For example, consuming more than 100% of the Daily Value of certain vitamins and minerals,
such as calcium, iron, vitamin A, and vitamin D, from supplements in addition to food sources
that contain these nutrients, may be harmful to your patient’s overall health.
This is an important point to stress with your patients…
more is not necessarily better.
And finally, products containing hidden pharmaceutical ingredients are sometimes falsely marketed
as dietary supplements.
These are among the most concerning products sold as dietary supplements because they significantly
increase the risk to consumers.
Common hidden drug ingredients include sibutramine, sildenafil,
tadalafil, and phenolphthalein.
[On-screen] Adverse Events
[Host] Because dietary supplements are not approved and often are not even reviewed by FDA before
they are sold to the public, it is particularly important that you and your patients report
any adverse events or reactions to FDA.
This is important information that FDA can use to evaluate the safety of marketed products
and, if needed, take action to protect the public from unsafe products.
You should notify FDA if you suspect that a dietary supplement may have caused an adverse
or unanticipated reaction for your patient.
For example, if your patient exhibits allergic, cardiovascular, gastrointestinal, gynecological,
musculoskeletal, neurological, ocular, psychiatric, pulmonary, rheumatologic, urologic or other
reactions, or if the situation resulted in an emergency room visit or hospitalization.
Although dietary supplement manufacturers are required to report serious adverse events
to FDA, the Agency encourages you and your patients to report any adverse reactions directly
to FDA.
Having a comprehensive picture of the situation can help FDA undertake a thorough evaluation
and follow up as needed.
In some cases, a single adverse event report can be very helpful to FDA in investigating
and taking action to protect public health
If you believe that a dietary supplement may be causing your patient to experience an adverse
reaction or illness, first tell your patient to stop using the product.
Then, notify FDA by submitting a report through the Safety Reporting Portal at www.safetyreporting.hhs.gov.
Your reports are crucial to help FDA better protect the public from unsafe products.
[On-screen] Talking to Patients About Dietary Supplement Use
[Host] Now that you know more about dietary supplements, FDA strongly encourages you to talk to your
patients about them.
During your review of their medical health history, ask your patients about what supplements
they are taking, how much, and if they have experienced any reactions.
This is also a good opportunity to counsel patients about the benefits and the risks
of taking dietary supplements.
Although some supplements can help ensure patients get enough essential nutrients the
body needs to function, remind your patients that dietary supplements cannot replace a
healthy diet and should not be used in place of medications.
In addition, patients should be cautious of dietary supplements with claims that sound
too good to be true.
You should also remind your patients that there are possible health risks associated
with combining dietary supplements, taking too much of a supplement, taking them instead
of or in addition to medications, and taking certain supplements
when having lab work or surgery.
Throughout this presentation, we’ve provided important information about dietary supplements,
including what information you should share with your patients.
But what does talking about dietary supplements with your patients look like in practice—your
practice?
Let’s take a peek into a doctor-patient consultation and get some insight.
[Doctor] So, at your last visit, I talked about increasing your dosage of that prescription
or maybe even switching to another drug.
Before I do that, I wanted to ask if you are taking any dietary supplements?
[Patient] Well, I’ve been taking a multivitamin for a while, and
sometimes I'll take melatonin just to help me sleep.
Oh, and I take calcium because dairy does not always agree with me.
[Doctor] Did another doctor recommend that you take these?
[Patient] No.
[Doctor] Well, can you tell me how much you're taking?
And how often?
[Patient] I take the multivitamin and calcium every day.
I don’t remember how much, but I just follow the directions on the label.
I just assume that's how much I should be taking, right?
[Doctor] Well, it depends.
But, it’s important for me to know how much you are taking.
So, when you get home, can you send me this information through the patient portal?
[Patient] Sure.
[Doctor] Also, have you had any issues tolerating the supplements?
Or have you experienced any unusual side effects, like a rash, coughing, dizziness, abdominal
pain, headache, fever, or hair loss?
[Patient] I don’t think so.
I’m just trying to improve my health.
[Doctor] I understand.
Just keep in mind that dietary supplements have both benefits and risks.
I sometimes recommend supplements for my patients who are not getting enough essential nutrients
from their diets, like the calcium you mentioned.
But you have to be careful when taking dietary supplements because they can also be harmful.
Some supplements can interfere with certain prescription medications
and even over-the-counter drugs.
And some might have unproven ingredients or be falsely marketed.
A big concern is that people might use a supplement in place of a prescription drug or take too
much of it.
[Patient] Wow!
I didn’t know that.
[Doctor] Did you know that dietary supplements aren’t approved by FDA?
[Patient] You know, I just assumed they were.
That’s pretty concerning.
[Doctor] From now on, if you’re thinking about taking a supplement, I’d like to discuss
it with you first, especially since you're taking a few medications.
And if you think you are experiencing any type of reaction to a supplement, stop taking
it and immediately contact the office.
We should also notify FDA of any adverse reactions to help protect all consumers.
And here, this information reviews some of the basic information we discussed today about
dietary supplements.
[Patient] This is great, thanks!
[Doctor] You bet!
[Host] There you have it. How to talk to patients about dietary supplements,
and why it’s so important.
For more information on dietary supplements from FDA and the National Institutes of Health,
Visit the FDA and NIH websites.
www.fda.gov/dietarysupplements www.ods.od.nih.gov
On behalf of the U.S. Food and Drug Administration and the American Medical Association, we thank
you for educating yourselves and your patients on this important topic.