Inactive Ingredients in Drugs Aren't Harmless

Alicia Farmer
March 15, 2019

When medications contain peanut oil, manufacturers print warnings on the labels, but for most other allergens or irritants, no warnings are given, and it is not easy to find out if a compound such as lactose or gluten is in the medicine, the researchers say.

Traverso and his team started by looking through the medical literature for reports of patients reacting to inactive ingredients.The researchers found some studies on patients who had allergic reactions to inactive ingredients such as lactose - present in about 45 percent of pills - as well as certain kinds of chemical dyes.

Traverso, who is also a biomedical engineer with an appointment at MIT, started exploring this topic with some colleagues by weighing pills in the hospital pharmacy.

Inactive ingredients may not be as immediately obvious as the active ingredients which must be clearly marked on, for example, a pill bottle.

In general, the amounts in a given pill aren't concerning.

If you are lactose intolerant and take a pill that uses lactose as an inactive ingredient, "it's probably not going to manifest in any significant symptoms", he says. "But as the number of pills you're taking [increases], then certainly you might cross that threshold". These "inactive" substances, like lactose or gluten, can also be the source of allergies and intolerances. But for a lot of these ingredients, "we don't really know today".

The Food and Drug Administration regulates these drug ingredients. But these additional ingredients often contain lactose, corns starch, sugars and other ingredients that can cause annoying or even painful reactions in some people.

Dr. John Kelso, an allergist and immunologist at Scripps Health in San Diego, California who wasn't involved in the study, doesn't see a cause for concern.

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We do know that reported allergic reactions to medications, which happen nearly instantaneously, are rare. In fact, it's usually a false alarm.

But those differences can matter for people with allergies or other sensitivities.

Overreaction to this worry can actually backfire. In most cases, doctors have no idea which of these ingredients will be included in the pills they prescribe to their patients, because there are so many different formulations available for any given medication.

"We realized lately that approximately 95 percent of patients who are labeled penicillin-allergic are not", he says, "either because they never were or because they had an allergy that waned with the passage of time". An allergist can test people to see if they're actually allergic to this useful and low-priced antibiotic. But neither tells people the actual quantity of these ingredients, Traverso noted. Of those, 11 are found in 10 percent or greater of medications. The full list of ingredients is often found in the brochure that goes along with the drug and can also be found in databases of the U.S. National Library of Medicine, he said.

Currently, when doctors write a prescription, they specify the type and dosage of the active pharmaceutical, but nothing about the inactive ingredients.

He and his colleagues have a patent pending on an algorithm that is created to make this sleuthing easier.

A new study led by a team of investigators from Brigham and Women's Hospital and Massachusetts Institute of Technology has found that the vast majority of the most frequently prescribed medications in the US contain at least one ingredient capable of causing an adverse reaction.

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