Wednesday, November 30, 2011

First scientific research into gluten in drugs

Do you spend a lot of time worrying about gluten in your prescription and over-the-counter medicine?

It's a topic I've researched and written about many times. The general conclusion is that gluten does not turn up in drugs that often.  But because it sometimes does and is not clearly labeled, we are left looking through everything from common pain relievers to prescriptions used for rare ailments to find that oddball medicine that might contain some form of gluten.

Now there is word that the National Foundation for Celiac Awareness has received a grant to conduct the first scientific research into the use of gluten in drugs. This is good news for everyone who is gluten free.

The $50,000 grant from the Food and Drug Administration will fund preliminary research that the NFCA says "aims to validate or nullify" anecdotal reports of gluten reactions to drugs from those who have celiac disease or gluten intolerance.

The research project goes by the rather cumbersome title, "Gluten in Medication: Qualifying the extent of exposure to people with celiac disease and identifying a hidden and preventable cause of an adverse drug event." The NFCA says the project will "characterize the problem of unlabeled gluten in medication and raise awareness of the potential harm that can occur to patients who ingest medications that they do not recognize as containing gluten."

My hope is that the research will mainly concentrate on objectively determining the extent to which gluten is found in the vast array of drugs available and in what amounts. We need to have that information to determine what kind of risk actually exists and how to proceed with steps for better labeling.

The NFCA is the leading advocate for better labeling of gluten in drugs, something that would surely be helpful to those with celiac disease or gluten intolerance. The group says the research will a first step in providing a foundation for further investigation within the FDA and scientific communities.

"To date, there has been no scientific research conducted to determine if the amount of gluten that is in medication results in harm to people with celiac disease or gluten sensitivity, although there are reports of significant patient reactions to gluten in medication," the NFCA says in a press release announcing the study.

Since we know that reactions to gluten are not a reliable way to determine the gluten-free status of a food or, in this case, a drug, scientific evidence is very important.

A drug's active ingredients, which actually treat an illness or condition, are gluten free. But inactive ingredients,  which make up the bulk of most medications, occasionally contain gluten, mainly in the form of wheat starch.

Everyone, including the NFCA, agrees that relatively few medications contain gluten, but poor labeling requirements make it difficult to identify them. As a result every drug becomes suspect.

Further complicating matters is the fact that prescription drugs don't have to list inactive ingredients on the label. The only way to find out what's in them is to ask the pharmacist or call the drug company.

While over-the-counter medications do detail inactive ingredients,  unlike food, the FDA does not require that the use of wheat be clearly spelled out on a label.

Loretta Jay, an NFCA consultant, and Dr. Robert Mangione, dean and professor of pharmacy at St. John's University, are leading the research team doing the NFCA study.  A survey of celiac disease patients will help the researchers select types of drugs reported to have caused reactions. The drugs will  tested to determine how many parts per million and milligrams per dose of gluten they might contain.

Currently, the best source of information about gluten in drugs can be found on a website run by Steven Plogsted, a pharmacist at Columbia Children's Hospital who regularly researches gluten in specific medications. Also, some over-the-counter products are now labeled gluten free.

Otherwise, determining a drug's gluten-free status can be an arduous and frustrating process for gluten-free consumers. Drug companies can be reluctant to give out information and often simply say none of their drugs have been tested to be gluten free. Other times they give conflicting and confusing answers to questions about ingredients and gluten content.

The valuable research being done by the NFCA could eventually lead to clear labeling of gluten in prescription and over-the-counter drugs. And that would make any pill easier to swallow for everyone who is gluten free.

Amy Ratner

1 comment:

Wendy said...

I was taking generic Paxil when I was diagonosed with gluten intolerance with out any problems. My company changed insurance providers, which also changed our mail order prescription pharmacy. They used a different generic drug supplier and I stared having problems with gluten, that I traced to the generic Paxil. I spent hours on the phone with the pharmacist trying to determine with of my medication was causing the reaction. Eventually, I had to change to the brand name Paxil at a much higher cost to avoid gluten contamination. Even the pharmacist had a hard time getting the information on the meds.