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Hidden gluten in prescription medications presents risk for those with celiac disease

Prescription pills. (Photo: AP)

WASHINGTON (WJLA) -- When you want to know what's inside the food you eat, from nuts to dairy you just check the label. But it's not that easy when it comes to medications you take. And a local advocacy group is fighting a federal agency to change that.

Michael Weber is fighting a battle. His personal issue is not just the Celiac Disease he copes with; it's fear at the pharmacy counter. Weber says, “It's very scary to think that the drug you're going to take is going to make you sick.”

Weber says he got sick years ago, trying to get better. He claims he took a drug with a hidden ingredient he says was not on the label: gluten.

“Until that time,” Weber explains, “I thought drugs were gluten free.”

It can be a potentially dangerous assumption for the 3,000,000 people in the United States with Celiac. Dr. Robert Hardi, a physician with Capital Digestive Care, says the disease has to be closely monitored, “It has a huge impact on patients' lives because from the time of diagnosis as long as they live they will have to be extremely careful with their diet.”

Hardi explains that if Celiac patients are not careful, they can get extremely sick. When people with Celiac consume gluten, Hardi says, it attacks their body and avoiding gluten is the only treatment.

Avoidance is something Weber says he couldn’t do without more information about his medications. So he filed a citizen petition with the Food and Drug Administration, requesting a wheat gluten ban in drugs and labeling changes. Then 7 On Your Side discovered, he waited seven years for a response from the feds.

Katie Einspanier, an attorney with the Washington, DC-based advocacy group Public Citizen, says there’s absolutely no excuse for the delay. 7 On Your Side asked the FDA to explain why it waited so long to respond. A representative said it couldn’t comment on that because of the litigation. That litigation was filed by Public Citizen on Weber’s behalf and prompted the FDA’s response this spring.

“It would be a simple solution if they could know one way or another, if the FDA could tell them on drug labels, yes your drugs contain gluten or no, they don't,” Einspanier said.

The FDA partially denied Weber’s request for a ban, telling 7 On Your Side gluten use in medication is extremely rare. The agency says it’s unaware of any currently marketed products. The agency also said in its response that it currently expects drugs to be labeled as containing wheat gluten.

But leading researchers disagree about the information that’s available. Dr. Steve Plogstead runs a website often cited by the National Foundation for Celiac Awareness. His site lists drugs that aren’t gluten free.

And as Michael Weber asks for better labeling, we found there’s still plenty of confusion. 7 On Your Side called some of the nation’s biggest drug companies, even their nurses and reps couldn't give us clear answers about ingredients. Dr. Robert Hardi admits some physicians may not even be aware of the potential for gluten in prescriptions. As a result, patients may be left to play pill detective, tracking down the background of every batch because suppliers can change.

Michael Weber doesn’t think Celiac patients should have to shoulder that responsibility. His lawsuit against the FDA has now been dropped following the agency’s response. But Weber, along with Public Citizen is considering other options, including a revised petition to the FDA. After years of battling for clarity, he’s undeterred in the fight.

“What would keep me motivated is I know I'm arguing for many other people beside myself,” Weber said.

As he considers options, the FDA says it plans to issue some guidance for the drug industry. It may also put information on its website about gluten to hopefully help people with celiac have greater confidence that the medicine they use will not harm them.

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