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The new research suggests that the vast majority of oral medications contain ingredients that can cause adverse effects in patients.
The culprits are ingredients called "inactive": hundreds of thousands of different additives that help in the manufacture of drugs but do not constitute the main functional component of the drug.
When a doctor gives you a prescription for a medicine, the most important part of the drug is what is called the API: the active pharmaceutical ingredient, the chemical meant for you treatment.
But API is not the only thing in the drugs that people buy.
Up to 99% of a tablet or tablet can be made up of excipients: supposedly inert fillers that would otherwise help the drug in terms of appearance, consistency , color, aroma or other physical properties.
Excipients, also known as blowing agents, are often listed as "inactive ingredients" on drug packages, but this term is a bit abusive.
Unlike the IPA, excipients are not supposed to have any direct therapeutic effect, which is why they are defined as "inactive", but that does not necessarily mean that they are inactive or inert. 39, another way.
"Although we call these ingredients" inactive ", in many cases they are not," says gastroenterologist Giovanni Traverso of MIT and Brigham Hospital and Women & # 39; s.
"Although doses may be low, we do not know what is the threshold at which individuals can react in the majority of cases."
Traverso was inspired by the study of inactive ingredients after being involved in one case five years ago in which a patient with celiac disease had poorly reacted to omeprazole, a drug used to treat stomach ulcers.
The formulation taken by the patient contained ingredients derived from wheat products that may contain gluten. These components could have been the reason why the patient felt sick after taking the medication.
"That really made me understand the little knowledge we have about tablets and their potential side effects," Traverso said.
In this new study, Traverso and other researchers badyzed the Pillbox public database, which contains information on more than 42,000 oral drugs marketed in the United States and more than 350,000 inactive ingredients used in the manufacture of these drugs.
On average, the tablets or capsules contain 8.8 inactive ingredients, but hundreds of them have 20 or more, and sometimes more than 30.
About one-third of inactive ingredients appear only once in the database, while others are common components (such as magnesium stearate, which is found in 72% of oral medications).
Generally, inactive ingredients account for more than 50% of a tablet, but sometimes up to 99%, says the team.
None of these statistics is necessarily problematic, but some of the data discovered by the team is of greater concern.
More specifically, 38 of the inactive ingredients identified by the team have caused allergic symptoms in the past, and 92.8% of all oral medications in Pillbox contain at least one potential allergen, while 55% contain less a FODMAP sugar.
"For most patients, it does not matter that there is a little lactose, a little fructose or starch," says one of the team members, the Biochemical data researcher Daniel Reker of MIT.
"However, there is a subpopulation of patients, whose size is currently unknown, who will be extremely sensitive to them and who will develop symptoms triggered by inactive ingredients."
The problem is compounded by the fact that, even though inactive ingredients usually appear on the package, their relative amount in the drug is not detailed.
In addition, when doctors prescribe medication to patients, they can specify only the dosage of the IPA, not the formulation itself – and it is sometimes impossible to avoid certain inactive ingredients in different formulations. The same medicine.
Risks can also be increased in older patients, who often take many medications, potentially exposing them to a harmful build-up of inactive ingredients to which they may be susceptible.
"A patient taking 10 prescription drugs would ingest an average of 2.8 grams of inactive ingredients a day," write the authors.
"It's a substantial amount of excipient material that is administered to patients every day and deserves special attention."
To summarize, there are many reasons why the team said more attention should be paid in the future to these unnoticed ingredients, as well as to the way in which they have gone unnoticed. are regulated and given to patients.
"Taking into account the effects of excipients will allow advanced formulations for drugs that are difficult to administer and could lead to personalized medicine for vulnerable subpopulations," the authors explain in their article.
"Such an badysis will allow clinicians to make conscious choices about formulations that are focused on the well-being of their patients."
It should be noted that three of the authors are listed as co-inventors in a provisional patent application for a system that uses algorithms to quantify and detail the inactive ingredients of the drugs.
On the one hand, it means that they might have a commercial interest in exposing the risks badociated with inactive ingredients, which we must not forget.
But I hope it also means that the problems they have highlighted become easier to solve one day, through an application or a website that can effectively explain what we are buying at the time. pharmacy.
"We were surprised by the results," Traverso told NBC News.
"It's about almost every pill and every capsule, and that's one thing we tend not to think about."
The results are reported in Translational medicine science.
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