Gluten in Medicine
Last year I was diagnosed with strep throat and was prescribed a medicine to get me back on my feet again. This should have been an easy recovery since I promised to follow my Doctor’s advice of lots of rest, fluids and to take my meds as prescribed.
The problem started at the pharmacy when no one could confirm the medicine I was prescribed was gluten free. My doctor had prescribed this medicine to me in the past and I had confirmed it as gluten free, but recently the formulation had changed just slightly. It now contained starch as an inactive ingredient, and did not list the source. It was after hours, and the manufacturer was closed. No information was given on the pharmaceutical company’s website.
I was torn. Do I take the medicine and take the risk of being exposed to gluten? Would the medicine even get absorbed into my body if I damage my intestines? What was worse strep throat or being exposed to gluten?
I thought to myself that this wasn’t fair. This medicine wasn’t something I had a choice on ingesting. I needed it. I didn’t have the luxury of contacting the manufacturer and waiting a week or two to hear if gluten was on the ingredient list, or not. This was medicine - not a jar of salsa that I could pass on buying unscathed until my gluten free due diligence was completed.
If I didn’t have strep throat I think I would have let out one big scream right there at the pharmacy counter.
Luckily I confirmed that my medicine was gluten free the next morning and only delayed my recovery a day or two.
This story is why I am sending three Cheers to Stop & Shop Supermarkets, ASHP (The American Society of Health-System Pharmacists) and the NFCA (National Foundation for Celiac Awareness) for an very informative Educational Session that I attended: Gluten in Medications.
Although this session was focused on educating pharmacists, pharmaceutical company representatives and national pharmacy organizations about celiac disease, why gluten in medicine is such a concern for celiacs and how celiac disease can affect the normal absorption process of medicines, it was an enlightening, useful, and a fantastic resource for any person diagnosed with celiac disease.
This seminar was right on target. The content was useful, applicable and presented to the attendees in an elementary manner, which included hands-on examples of analyzing medicine labels and discussing possible gluten contaminants. The session ended with an interactive Q&A session.
Without hesitation I can say that for celiacs everywhere this educational session is a must-attend.
The speakers of the seminar included Dr. Daniel Leffler, Director of Clinical Research – The Celiac Center at Beth Israel Deaconess Medical Center; Priti N. Patel, PharmD, BCPS, - Clinical professor of the St. Johns University College of Pharmacy; Gerry McEvoy, ASHP Vice president, Drug informationl and Vanessa Maltin, NFCA Director of Programming & Communication.
Some of the more interesting and useful takeaways of this educational seminar include:
History of Celiac Disease: This isn’t something new!
Celiac disease was first remarked about in 50 A.D. when Aretaeus the Cappadocian, one of the most celebrated of the ancient Greek physicians wrote in The Coeliac Affection, “If the stomach be irretentive of the food and if it pass through undigested and crude, and nothing ascends the body, we call such persons koeliacs.”
Celiac was then mentioned in 1888 when Samuel Gee, an English physician who gave the first modern-day description of celiac disease in a lecture in 1887. His interest in the history of medicine, and ability to read ancient Greek, meant Gee was familiar with the work of Aretaeus of Cappadocia. Gee stated, “On the Coeliac Affection…if the disease is to be cured at all it must be by means of diet.”
After that, celiac disease was only truly defined until 1950 when a Dutch pediatrician, Willem-Karel Dicke noted that some of his patients who were sickly improved miraculously during World War II when grain imports were stopped.
Knowing that celiac disease existed in 50 A.D. is a surprise to most people who are just starting to recognize common place terms such as “celiac disease” and “gluten free” in every grocery store aisle, classrooms and doctor’s office.
For many sufferers it comes as a shock and disappointment that celiac disease is just starting to get the attention and credibility it deserves although it was recognized over 1,950 years ago.
Celiac Disease is not rare: It can closely be compared to Type 1 diabetes!
According to the American Journal of Gastroenterol it was previously estimated that 1 in every 5,000 people in the United States had celiac disease. Currently that figure has risen to one in every 100 to 250 people who have celiac disease. These figures are raising at a rate that easily makes celiac disease almost comparable to Type 1 Diabetes, which afflicts 2 in every 1,000 people in the United States.
However, in the United States the number of known celiacs is about 40,000, with the projection of 2.1 million people of having celiac disease. For every known celiac there are 53 undiagnosed individuals.
Why is Celiac Disease getting so popular?
Due to improved diagnostic tools and awareness over the past 20 years, the diagnosis of celiac disease is increasing over 25% every year at Beth Israel Deaconess Medical Center in Boston, according to Dr. Leffler. This makes the diagnosis of celiac disease more prevalent than the diagnosis of other autoimmune disorders such as Crohn’s disease, Multiple sclerosis, Type 1 diabetes, and asthma.
Inactive ingredients are gluten carriers in medicines!
Priti Patel, the Director of the Drug Information Center at St. John’s University College of Pharmacy stated that the biggest question she is asked daily is: “Is my medicine gluten free?”
She stated that most times the drug itself is gluten free, but the hidden causes are the inactive ingredients, including:
- Excipients: added to provide suitable size or consistency
- Binders: added to cause particle to adhere
- Surfactants: reduce interfacial tension in small concentrations / emulsifiers
- Suspending agents: provide insoluble drugs in a liquid dosage form
- Sweeteners: flavoring agents
- Thickening agents: such as fillers and gums
Ingredients in medicine (both over-the-counter and prescription) do not have to be labeled the same as food products:
Currently the FDA has no requirements to label the risk of gluten in drugs and no specific precautions for celiac disease. This is a major issue!
When an excipient such as starch is listed as an ingredient on a medicine it is not necessary for the manufacturer to list the source since the inactive ingredients in drugs are not regulated like the active drugs in medicines. It is also important to note that contents of excipients change by the lot number!
To indicate how prevalent unspecified excipients are in medicines a labeling search done in the DailyMed on March 26, 2008 found over 1/3 of all prescription drugs have starch in them. Out of those found with starch, 65% of them do not specify the botanical source.
Doesn’t the Food Allergy Labeling & Consumer Protection Act (FALCPA) of 2004 cover medicines too?
NO! Medicines are not covered under the FALCPA ruling of requiring labeling of the eight most common allergens including milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. All eight must be listed by their common name on the labels of packaged foods. No other similar labeling requirement exists for medicines either.
Is the FDA able to change this? Have they changed labeling requirements for other ingredient precautions in the past?
The FDA required labeling requirements for the presence of Aspartame, in both food and drug products. Phenylketonuria (PKU) is a rare (the incidence of PKU in the United States is only 0.005%), inherited metabolic disease that results in mental retardation and other neurological problems when treatment is not started within the first few weeks of life. PKU requires a very strict and well-maintained diet.
Elevations of blood phenylalanine are dangerous for those with PKU. This means that those with PKU should avoid aspartame at all cost due to the 50% phenylalanine levels.
Although those with PKU have a more immediate and severe effect when ingesting aspartame compared to a celiac exposed to gluten, it is important to note that PKU is a much rarer disease and one that the FDA took labeling action on.
Is The American Society of Health-System Pharmacists (ASHP) making any recommendation on making changes with the listing of gluten on medicine labels? Are they doing anything to educate pharmacists?
The ASHP has established proposed policies the summer of 2008 advocating that manufacturers declare the name and derivative source of all excipients in drug products on the official label.
They are also proposing to educate health-system pharmacists about celiac disease and the effects of gluten on those diagnosed with celiac disease.
Lastly, they are fostering definitive research on the influence of gluten in drug products on celiac disease.
How can a consumer make sure there is no gluten found in their medicine?
A proactive approach must be taken to ensure that both over the counter and prescription drugs are gluten free. Here are a few tips in determining if your medicine contains gluten:
- Due Diligence!: Be diligent in asking questions to both your doctor and your pharmacists. Speak up! Ask questions!
- Prescriptions / drugs that change: Be cautious if your doctor gives you a new medicine or if you notice that the look, shape or color of an existing prescription changes. Like food, medicine changes formulations quite often, and the new formulation may contain gluten.
- Brand name vs. Generic drugs: Be wary of any substitutions of the medicine that was prescribed from your doctor. Many brand name drugs may be gluten free and the generic version of the drugs may contain gluten. Most health insurance companies will comply with doctor’s orders and allow the administration of brand names if specifically instructed.
- Do research on websites that provide information on gluten in medications: A fantastic website that offers a fantastic source of information in determining if your over-the-counter or prescription medicine contains gluten is http://www.glutenfreedrugs.com. This website is maintained by Steve Plogsted, a Pham.D at Columbus Children’s Hospital. The site contains information on most medications and is a "must" website that all celiacs should bookmark.
Although the American Society of Health System Pharmacists, the Food & Drug Administration and awareness groups such as the National Foundation of Celiac Awareness are making great strides in the labeling and determining the source of all ingredients in both prescription and over the counter medicines, it is currently up to each celiac sufferer to self-advocate and research all medicines for gluten content.
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