<<Disclaimer: Verify this information before applying it to your situation.>>
Pharmaceutical Advice
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Anne Laginess, Pharmacist
summarized by Jim Lyles
At our March meeting, Anne Laginess spoke. Anne is a registered staff
and clinical pharmacist at Henry Ford Hospital, where she has worked
for 17 years. She spoke with our group two years ago, and then spoke
at the national CSA/USA conference in Detroit later that same year.
What follows are some highlights of her talk.
Some pharmaceutical products contain gluten, generally in the inert
ingredients (also called excipients). You should be suspicious of any
of these ingredients, as they might or might not have come from a
gluten-containing grain:
starch hydrolyzed protein
cross linked starch modified food starch
sodium starch glycolate malt
hydrogenated vegetable oil maltodextrin
alcohol malt extract
pregelatinized starch
What is the significance of gluten in pharmaceutical products? Small
amounts of gluten in pharmaceutical products can be harmful to those
with celiac disease, particularly if the patient is taking the
medication for a long time.
There are conflicting reports on the effects of small amounts of
gluten on celiacs. Comparing the various studies is difficult, as
some refer to gluten, others to gliadin or prolamine. Here are some
examples of reported data regarding gluten in pharmaceuticals:
* In some celiacs 1-2 mg. of prolamine per day is toxic. In
others, 2-12 grams of gluten per day is tolerated without
symptoms.<2>
* 4 out of 10 patients who ingest 1-2 mg. gliadin per day for 6
weeks have symptoms. Patients may have no symptoms while
ingesting up to 5 grams of gluten per day, but their intestinal
mucosa does show damage.<3>
* Some pharmaceutical products may contain 0.015-1.84 mg. of
gliadin per dose.<4>
* In pharmaceutical products, the amount of wheat starch per dose
is 4-167 mg., providing up to 0.35 mg. of prolamine per dose.
If taken three times a day, this may cause a problem for a highly
sensitive celiac.<5>
There are several ways of determining if a pharmaceutical product
contains gluten:
1. Product Package Insert: This data is enclosed in each package of
tablets, capsules, etc., that the pharmacy receives. Check with
the pharmacist to see the insert; get your physician to request
it for you if necessary. This information is also available in
the Physician's Desk Reference (PDR), which you can usually find
at your local library.
2. Manufacturer of the Medication: Contact the manufacturer. The
PDR contains a list of address and phone numbers. Also, the
product packaging or product package insert usually contains the
address. [There is also a list of about 250 pharmaceutical
companies with addresses and phone numbers in your new patient
packet, dated October 1994.--editor]
3. Drug Information Centers: Specialized information centers are
available to health care practitioners at many teaching
hospitals. If your physician is affiliated with a teaching
hospital, ask for help from this source.
4. Drug Information Centers for Consumers: One service based in
Chicago is called "Call-Our-Pharmacist". It is available day or
night. Call 1-800-522-5225 for information about the service.
Call 1-900-903-7847 for verbal and mailed information; have the
drug name and letters/numbers off of the capsule/tablet if
possible. [The cost for the 900 number is $1.99 per
minute.--editor]
Be careful about evaluating data you get from manufacturers and drug
information centers. Ask them where they got their information.
Sometimes you'll get conflicting data from different sources.
Consider these points:
* Drug manufacturers tend to concentrate on the active ingredients
in the medications they produce, and do not always know if an
inert ingredient contains gluten.
* Drug information centers obtain their information from published
articles and from manufacturers.
* Many published articles regarding gluten in pharmaceuticals refer
to data obtained from manufacturers rather than from independent
laboratory testing.
* Manufacturers continually change formulas and suppliers,
particularly with generic equivalent drugs. Ask for both the
distributor name and the manufacturer name (and the package
insert, if it's available) every time you have a prescription
filled. Compare it to your previous information to see if
anything has changed.
How can you avoid gluten in pharmaceuticals? If you have a choice:
* Choose smaller tablets containing the same dosage; there will be
less inert ingredients. Or choose a higher strength version, and
use half tablets.
* Avoid taking pharmaceuticals that aren't really necessary.
* For children, crush tablets and mix with applesauce, instead of
buying elixirs with alcohol.
* On the other hand, consider alcohol-free liquids when the tablet
form contains gluten.
* Check different brands. The active ingredients may be the same,
but the inert ingredients often vary.
* Try a different approach in treating symptoms. For example,
consider inhalers, salt water gargles and nose sprays (short-term
use ONLY) for cold symptoms. Eat fresh fruits/prunes and take a
daily walk instead of using a laxative.
Anne Laginess suggests reporting adverse drug reactions to the Food &
Drug Administration (FDA) and to the manufacturer. Your health care
provider already does this when there is a serious adverse drug
reaction. However, the FDA form does provide a place to indicate if
you are not a health professional. If individual celiacs report all
gluten reactions to medications, the FDA and drug manufacturers will
begin to accumulate data on celiacs. This will promote awareness and
hopefully will cause manufacturers to scrutinize ingredients more
carefully when drugs are reformulated.
Anne provided a copy of this form, which you can bet by calling the
800 numbers listed below. Feel free to copy this form and fill it out
each time you have a problem with a medication or dietary supplement.
On the back of the form are some tips regarding the use of the form
which I'll highlight here:
* File a report even if you're not certain the product caused the
event, or you don't have all the details.
* Report product problems such as quality, performance, or safety
concerns such as suspected contamination, defective components,
or poor packaging or labeling.
* Fill in the sections on the form that apply to your report. (Use
section C and skip section D for gluten-related problems.)
Attach additional pages if needed. Send the form to the FDA or
the manufacturer (or both).
* Important phone numbers: To fax the report call (800) FDA-0178.
To file a report by modem, call (800) FDA-7737. For more
information, or to report quality problems, call (800) FDA-1088.
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