Concerns about the ingredients of the "inactive" pill



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When the pharmacist carries out a prescription, the active ingredients in the drug may correspond to those prescribed by the doctor, but the inactive substances contained in tablets or capsules could pose a risk to the health of the patient, according to a new study conducted at home. United States.

Researchers at the Massachusetts Institute of Technology (MIT) in Cambridge, Mass., And Brigham and Women's Hospital in Boston, have discovered that almost all over-the-counter and prescription tablets and capsules contain ingredients that can cause symptoms. allergic reactions or irritations.

Their report, published in the journal Translational medicine science, says that with the medications that doctors want to administer, the medications they prescribe are mostly ingredients that fall into the category of inactive ingredients, called "excipients," usually considered benign. They are added to help stabilize the compound or help with the absorption of the drug.

Decades of pharmaceutical development have led to an understanding of inactive ingredients and their desired properties. The researchers, led by Daniel Reker of MIT, said that pharmaceutical companies often design formulations by borrowing thousands of known inactive compounds, "because the approval of new excipients may require a thorough toxicological profile."

However, it is said, "An increasing number of clinical reports have documented adverse effects triggered by an inactive ingredient of a drug".

The researchers analyzed the precise composition of thousands of drugs based on information contained in the Pillbox, a database maintained by the US National Library of Medicine, and the German Gelbe List database, sometimes referred to as the Pharmindex Yellow List.

For example, the researchers note that, although lactose intolerance is present in 75% of the world's population, lactose is' commonly used in 45% of oral solid dosage forms, with a lactose content reaching nearly 600 mg per tablet.

Again, 100% of the hormone progesterone and 62.5% of the anticonvulsant capsules of valproic acid contain peanut oil.

In addition, 18% of pharmaceutical manufacturers reported that their drugs contained gluten, and while 69% reported manufacturing gluten-free products, only 17% tested their products and could provide documentation of the tests performed.

Other ingredients listed in the report include chemical dyes, such as tartrazine, suspected to cause severe reactions in patients with allergic or asthmatic conditions. Reker and his colleagues found that "33% of all drugs contain at least one chemical dye associated with allergic reactions in patients."

"For most patients," says Reker, "no matter if there is a little lactose, a little fructose or a little bit of starch.

"However, there is a sub-population of patients, of currently unknown size, who will be extremely sensitive to these and will develop symptoms triggered by inactive ingredients."

These problems are exacerbated by what the report calls "polypharmacy" or by the simultaneous use of multiple drugs. For example, 39% of Americans over the age of 65 take at least five prescription medications a day, and 11.7% of a similar cohort of Swedes take more than 10 prescription medications a day.

"A patient taking 10 prescription drugs would ingest an average of 2.8 grams of inactive ingredients a day," the researchers said.

"It's a substantial amount of excipient material that is administered to patients every day and deserves further study."

The report's lead author, Giovanni Traverso, a gastroenterologist at Brigham and Women's Hospital, began looking into the issue about five years ago. One of his patients, who was suffering from celiac disease, had reacted badly to omeprazole, an acid suppressor commonly used in the treatment of stomach ulcers.

The patient had received the drug containing ingredients derived from wheat products, potentially containing gluten, but this information was only available from the manufacturer at that time. The patient had reported feeling sick from the medication a week after taking it.

"It really made me understand the little knowledge we have about tablets and their potential side effects," says Traverso. "I think there is a huge underestimation of the potential impact of inactive ingredients."

The researchers hope their findings will help raise public awareness of the potential risks of inactive ingredients for some patients. New regulations requiring pharmaceutical companies to provide more information on inactive ingredients in their formulations may help doctors to clarify more easily whether a given ingredient should not be included.

The researchers also hope that pharmaceutical companies will develop more alternative formulations for patients allergic or sensitive to certain ingredients.

"I think all of these things really have to come together," says Traverso. "Education, increased awareness and legislation are all important."

He and his colleagues are currently working on a follow-up study in which they interview health care providers to determine the extent of this problem. They also hope to conduct clinical trials to study the amount of lactose or other common inactive ingredients that manifest as symptoms in people with intolerance to these ingredients.

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