When I was initially diagnosed with Crohn’s disease in 2005, I went home from the hospital on 22 pills a day. As the weeks passed and the steroid was tapered, that pill count dwindled to six. Six Asacol. For those who don’t know what Asacol is, it’s considered a 5-ASA medication. Chances are, if you have IBD, you’ve either been on or are currently taking this as part of your daily treatment regimen. Out of the approximately 1.6 million Americans who have IBD, more than 250,000 are currently on this type of medication. That may seem all fine and dandy, but did you know 5-ASA’s are not FDA approved for Crohn’s patients?

Yes, you read that correctly. As a Crohn’s patient myself, I spent three years on Asacol and from 2014 until just recently I was on Lialda (mesalamine). After seeing a discussion on Twitter led by Dr. Peter Higgins, M.D., Ph.D., M.Sc., questioning the use of this class of drug for Crohn’s, the topic piqued my interest. Here’s what Dr. Higgins has to say about the subject.

NH: Given that there’s no evidence that 5-ASA medications are beneficial to Crohn’s patients (and not FDA approved), why are they being prescribed to more than 250,000 patients?

Dr. Higgins: “As best I can tell, this is because of failure of medical education, too many doctors getting their drug information from drug reps, and doctors fearing the risks of getting sued for using effective drugs. It’s uncommon for doctors to get sued for under-treatment of Crohn’s disease, which may need to change for doctors to change their behavior. Some doctors could be using 5-ASA’s as a placebo, and surprisingly, some doctors might not really understand the difference between Crohn’s disease and ulcerative colitis in terms of 5-ASA response.”

NH: Is there any additional benefit if a patient takes a 5-ASA med along with their biologic?

Dr. Higgins: “For small bowel Crohn’s, definitely not. Also, a recent study for ulcerative colitis showed no additional benefit for patients on biologics to continue 5-ASAs.”

NH: As someone with Crohn’s disease in my small bowel, I’ve been told in the past by a GI that 5-ASA’s lower my risk of colon cancer, thoughts?

Dr Higgins: “Anything that reduces colon inflammation will reduce the risk of colon cancer in IBD. Generally, patients with milder ulcerative colitis end up on 5-ASA, and therefore have lower risk of colorectal cancer (because of less disease activity, not necessarily the drug). There’s a correlation, but probably not causation. Studies show the most important predictor is control of inflammation, rather than what drug you are on, for preventing colorectal cancer in ulcerative colitis (or Crohn’s colitis).”

NH: As far as the cost for the patient, insurance companies, healthcare system in general—is this more about business/making money than treating the disease?

Dr. Higgins: “For the manufacturers of 5-ASAs, this is about making money in Crohn’s patients (an extra, bonus market with little effort on their part). If pharmaceutical companies wanted to do the right thing, they would be out talking to docs about stopping 5-ASA in Crohn’s and using it appropriately in ulcerative colitis. But the drug companies don’t have an incentive to spend the money to do a campaign to reduce drug use. Technically, it is illegal to market 5-ASA’s for Crohn’s, so drug reps choose to avoid the subject entirely.  I find the health insurance company complicity puzzling. Maybe it’s cheaper than biologics, because many insurance companies go out of their way to block the use of therapies that are not FDA approved.”

NH: If Crohn’s patients are on this medication, what’s your advice for them?

Dr. Higgins: “Talk to your doctor. Ask why you are on a medication that is not approved for Crohn’s disease. Ask about the FDA-approved options that *are* effective for Crohn’s. Ask your doctor how well-controlled your intestinal inflammation is. You can measure disease inflammation the following ways:

• By CRP (C-reactive protein) or ESR (SED rate) or FCP (fecal calprotectin)
• By CTE (for patients over 35 years old) or MRE
• By endoscopy if reachable with a colonoscope
• By capsule endoscopy if not reachable with a standard scope

If your inflammation is not well controlled, you should be on a more effective medicine to reduce your risk of strictures, obstruction, fistulas, abscesses, perforations, cancer, flares, steroids, hospitalizations, and surgeries.”