<<Disclaimer: Verify this information before applying it to your situation.>> Pharmaceutical Advice --------------------- 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.