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The annoying, even fatal, side effects of a medication may actually not be caused by the medication itself, says a new study released on Wednesday. Sometimes the substance used to make the pills easier to use – the inactive ingredients – can trigger allergies or intolerances.
Doctors have sometimes observed cases of allergy caused by the inactive ingredients of a drug, including dyes, sugars and even food. But according to study author Carlo Traverso, a gastroenterologist at Brigham and Women's Hospital and an assistant professor in the Department of Mechanical Engineering at MIT, no large-scale study has attempted to measure the risk that these ingredients could present.
Traverso and his team decided to review the ingredients of some of the most commonly prescribed drugs taken orally in the United States. Among these drugs was simvastatin, a cholesterol-lowering drug; Gabapentin, an anti-epileptic drug also used to treat nerve pain; and amoxicillin, a widely used antibiotic. They also reviewed the medical literature looking for cases of people likely to have been sick because of these filling ingredients.
Unsurprisingly, they found that inactive ingredients made up the bulk of most drugs, averaging 75% of a drug's mass. They also discovered cases of drug-related allergy or intolerance related to 38 of these ingredients, including peanut oil, lactose or glucose. And almost all the drugs examined, at least in some formulations, contained at least one of these possible allergens or irritants.
The results of the study, published in Science Translational Medicine, are intended to raise awareness more than anything else. And there are still many unanswered questions. On the one hand, we do not know how often these ingredients make people sick. On an individual basis, the risk would strongly depend on the amount of a trigger ingredient in that pill, the severity of a person's hypersensitivity and the number of medications taken by that person.
"For many of these [ingredients]It's probably low enough to say no, "Traverso told Gizmodo. "But for someone with severe lactose intolerance who takes a lot of medications, for example, it could very well be enough to cause serious symptoms."
We know that reported allergic reactions to medications, which occur almost instantaneously, are rare. But Traverso and his team point out that many more people report late reactions to food and other triggers, such as lactose intolerance. And although labels and doctors explicitly warn patients of allergic triggers such as peanut in their medications, we are seldom aware of these other ingredients, which are present in many medicines. The authors noted that more than half of the drugs studied contained at least one FODMAP, a group of sugars and carbohydrates associated with episodes of irritable bowel syndrome and other digestive problems.
Currently, patients can search for ingredients of a drug in materials provided by a pharmacy next to the drug. And the publicly accessible Pillbox database, administered by the federal government, contains similar information on more than 40,000 oral drug formulations. But neither of them tells people the actual amount of these ingredients, noted Traverso.
He hopes that his team's work will inspire efforts to create more detailed databases and labeling, as well as pressure pharmaceutical companies to develop alternative formulations of their drugs. The research should also aim to determine how often people become really sick because of inactive ingredients, especially in groups such as the elderly (who often take more than one medication at a time). And in the near future, the team plans to unveil a tool that will allow people to become more familiar with the ingredients of their medications.
"We are not saying that everyone should stop taking these drugs," he said. "But people with allergies or intolerance should have the opportunity to know if they need to worry about certain medications."
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