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Feb/Mar 2012 Issue
Is There Gluten in Your Medicine?
The Rx for finding gluten-free drugs
When you’re under the weather, the last thing you want to worry about is whether your prescription drugs will make you sicker. Does your medication contain gluten? Unfortunately, this can be a tough question to answer. Gluten (like other common allergens) doesn’t have to be listed as an ingredient on prescription or over-the-counter medications.
Pharmacist Steve Plogsted says he’s only come across one prescription drug voluntarily labeled gluten free – and he should know. Plogsted, who works full-time at Nationwide Children’s Hospital in Columbus, Ohio, has dedicated much of his free time over the past decade to identifying which drugs are safe for those who must avoid gluten, compiling his research on his popular website, glutenfreedrugs.com.
Plogsted’s special interest in gluten and medications began in 1996 when he was asked to speak to a celiac disease support group about gluten-free drugs. Since then, he’s presented at countless celiac groups and national celiac conferences. He also teaches a celiac course to 150 pharmacists each year.
Plogsted took time out of his busy schedule to sit down with Living Without’s senior medical correspondent Christine Boyd.
Christine Boyd: People with celiac disease and gluten sensitivity spend a lot of time ensuring their food is gluten free. How concerned should they be about gluten in their medications?
Steve Plogsted Although many medications are gluten free, there’s always the possibility of gluten or gluten contamination. Drugs are made up of one, sometimes two, active ingredients and an average of seven to eight inactive or filler ingredients. The fillers provide bulk and shape and may also help with absorption of the medication. And fillers are where you may find gluten. As a rule of thumb, it’s a good idea to check all new medications for gluten.
Yet confirming that a medication is gluten free is often easier said than done.
That’s right. Back when I first started researching gluten in medications in the late 1990s, manufacturers didn’t always know what I was talking about. They’d say, “You’re looking for what?” Then they’d do some research and I’d usually get a straight “yes” or a “no” from them. In the 2000s, as awareness of celiac disease started to grow, they began to pull back a little and get less affirmative about the presence of gluten. Now the answer is typically that there’s no gluten intentionally added but they can’t guarantee the drug is gluten free.
Is that because there’s no requirement to test for gluten?
In part, yes. The FDA doesn’t require manufacturers to test individual ingredients or the final product for gluten. And that hasn’t changed. I think what has changed today is how much misinformation is out there. When I’m told by a drug manufacturer that a medication may be contaminated by gluten or that they can’t guarantee it’s gluten free, I always ask what specific ingredient is in question. I’m often told it’s a sugar alcohol like mannitol, xylitol or sorbitol. Although these artificial sweeteners could have been derived from a wheat source, by the time they make it into a pharmaceutical grade product, they’re so highly refined they’re gluten free. According to many of the national celiac organizations, as well as other experts in the field, they’re gluten free. But the manufacturers will say it’s 100 percent contaminated [with wheat] and not to use it. What are people supposed to do in this case? This has become my biggest challenge lately.
What’s driving all this misinformation? Would it help to have a definition from the FDA on exactly what “gluten free” means?
The FDA has not yet defined what gluten free is in the pharmaceutical world. What appears to be the problem, I believe, is that pharmaceutical manufacturers are borrowing—and taking too far—a page from the FDA’s Food Allergen Labeling and Consumer Protection Act, which requires companies to disclose on their label when any of the top eight allergens, one of them being wheat, are present in their food product.
A case in point: One company recently told consumers that one of their products was contaminated with gluten. When asked the source of the gluten, they said it was from corn gluten. The company’s policy was “gluten is gluten” and they weren’t going to distinguish between them. In fact, corn gluten is entirely different from the gluten found in wheat, barley and rye. Corn gluten is not a problem for those who have celiac disease or gluten sensitivity.
By the way, some form of corn is in about 30 percent of drugs. One of the more challenging cases I’ve had was filling prescriptions for a young girl with celiac disease who was also allergic to corn.
Is it possible to read a label and determine for yourself if a medication is gluten free?
You can learn to identify whether or not a medication contains a starch. If it doesn’t contain a starch, there’s a very high chance it’s gluten free—and not cross contaminated with gluten either.
What do you need to look for?
If you have an over-the-counter medication, read the inactive ingredient list on the back of the box. If you have a prescription medication, read the inactive ingredient list in the package insert, the document tucked in with your prescription. Note that package inserts can be downloaded from most drug manufacturers’ websites. This information is also available at dailymed.nlm.nih.gov/dailymed/about.cfm. Look for the words, pregelatinized starch, sodium starch glycolate, dextrin, dextrate, cornstarch or just simply, starch.
Don’t most medications contain a starch?
A study done several years ago found about a third of the oral medications contained some form of starch. When starch is used, the FDA doesn’t require manufacturers to specify its source. As a result, manufacturers may leave it as “starch.” That gives them the option to change what they’re using. It could be corn today, wheat tomorrow. But most don’t switch because there’s the potential that the drug’s absorption characteristics may be different.
If you see a starch, what should you do?
Just because a medication contains starch doesn’t mean it contains gluten. The source of the starch could be corn, potato, tapioca, rice or wheat. I’ve never seen barley or rye starch. If the source of starch isn’t identified (sometimes it’s put in parentheses), call the manufacturer and ask, just like you would for food. You can also ask your pharmacist if there’s an equivalent medication made without starch. And although it’s not a foolproof strategy, I’ve never encountered an oral liquid that contains gluten. So see if a liquid form is available.
What about generics?
What you need to keep in mind is that generics aren’t required to have the same inactive or filler ingredients as their brand name counterparts. Even if the brand name is gluten free, the generic may not be. In addition, what generic you get from your pharmacy may change periodically. When your doctor tells the pharmacist to fill your prescription with a generic, you’ll get whatever generic the pharmacy has at that time. That means using generics may require more vigilance on your part to ensure they’re gluten free. If your medication changes color, size or shape, be sure to re-verify.
Do you think we’ll have gluten labeled on drugs in the future?
I do. Not long ago, some members of the American Society of Health-Systems Pharmacists testified before the FDA to get gluten and other allergens put on drug labels. Celiac organizations have applied pressure, too. There are a lot of people pushing for it.
What can people do in the meantime?
First, form a good relationship with the pharmacists at your drug store. If they’re not helpful, find a new pharmacy. Second, don’t wait until the last minute to order or refill a prescription. That way, if you get a different generic from the pharmacy you’ll have more time to verify or switch it, if necessary. Third, always look at the medication before you leave the pharmacy to be sure it’s the same as what you had before. Once you leave the pharmacy, by law, the medication can’t be returned. In some cases, it can’t be refilled either. Insurance companies may not pay for a second prescription. They may also refuse to cover the brand name medication. Try to find out in advance what documentation may be required by your insurance company to switch to a gluten-free medication, which could be the brand name. Finally, start reading your drug labels and get comfortable spotting sources of starch. You may also want to keep a list of medications you’ve verified (and the dates) and carry it as a “cheat sheet.”
Even if a medication is gluten free, it can still cause side effects that may seem like celiac symptoms. You could be sensitive to any one of the fillers. For example, mannitol and sorbitol are gluten free but can cause diarrhea. In addition, the active ingredients in some drugs are known stomach irritants. Lots of antibiotics cause gastrointestinal distress. When you fill a new prescription, ask your pharmacist if the medication may cause stomach upset. That can save you the headache of wondering if it could be gluten contamination or just the drug, working as expected.
So what’s the one and only prescription drug you’ve found that’s labeled gluten free?
Prednisone tablets. They’ve been marked gluten free for many years. Hopefully they’ll soon have company.