My Observations on NPR’s Story, “Overlooked Ingredients In Medicines Can Sometimes Trigger Side Effects”

My Observations on NPR’s Story, “Overlooked Ingredients In Medicines Can Sometimes Trigger Side Effects” | Blog#42

My good friend, Andrea, tagged me on her post of the March 13th edition of All Things Considered included a segment by reporter, Richard Harris, titled: Overlooked Ingredients In Medicines Can Sometimes Trigger Side Effects. The topic is near and dear to me as I’ve not only managed my own allergies for decades, but those of my 21 year old daughter whose allergies are not only multiple, but extreme in their manifestation and sensitivity.

The piece is not only overdue, but the knowledge contained within it, quite sadly, is something every citizen should know and doctors proactively account for as a part of the care they provide. The fact that doctors are trained to ask patients about allergies to drugs but completely ignore inactive ingredients is negligent. What’s worse, when doctors’ practices do ask about all allergies, they almost never use the information they’re given and cross-check it before prescribing medications. One can say the same about pharmaceutical companies and the process used in choosing what inactive ingredients to use with a particular drug. Allergies are ubiquitous. Celiac Disease is prevalent enough for all parts of the medical profession to be conscious of it and the implications of prescribing or manufacturing oft-used drugs that contain gluten. The fact that none of those concerns are taken into account is malpractice.

The first issue I have is with the title of the piece. Inactive ingredients aren’t merely overlooked. They are completely ignored. There is a difference. Were they overlooked, there would be versions manufactured in smaller batches to accommodate patients with allergies. There aren’t. If a drug isn’t available sans an offending allergen, the only recourse is to have a version of it compounded (specially prepared) at a compounding pharmacy. Many health insurance plans no longer cover compounded medications even if the patient has life-threatening conditions.

The second issue is that an allergic reaction isn’t exactly a side-effect. It is an adverse event and it can be deadly or, in the case of Celiac Disease patients, cause permanent damage. A side-effect can be drowsiness, dry-mouth, bloating and a bevy of other, unexpected and even unwanted effects from a substance. An allergic reaction is more than that.

The problem for allergy sufferers who have to resort to compounded medications is that they are restricted to drugs that have come out of patent, as pharmaceutical companies will not sell the pure powder form of patented drugs. This is a profit issue. Compounding medications is expensive. It requires manually preparing each capsule, preferably in a clean-room setting. A $4 bottle of Ibuprofen turns into a $68 purchase if you need it to be compounded to avoid any or all of the following inactive ingredients

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

In my daughter’s case, the most obvious ingredients, corn, hypromellose, lactose, magnesium stearate (usually from corn), red iron oxide, and stearic acid would be excluded. The others would also be excluded because their source doesn’t have to be declared. Sodium starch glycolate can be made from a number of sources:

Sodium Starch Glycolate
Excipient (pharmacologically inactive substance)

What is it?

Sodium starch glycolate is the sodium salt of carboxymethyl ether. Starch glycolates are of rice, potato, wheat or corn origin. Sodium starch glycoate is a white to off-white, tasteless, odorless, relatively free flowing powder.

Sodium starch glycolate isn’t necessarily gluten-free and there is no way to know whether or not it is. There is another substance, glycerin, which can be made of multiple vegetables but doesn’t come with a requirement that manufacturers declare the source. If you are allergic to soy or corn, vegetable glycerin is most likely a problem for you.

The source of inactive ingredients isn’t the only concern for a lot of patients. Their nutritional value, the carbohydrates they add to the diet, can be of extreme import. If we stay without Ibuprofen example, two 220mg pills contain three quarters of one gram of carbohydrates. To someone who is on a medically-necessary ketogenic diet for Epilepsy, taking Ibuprofen means they need to alter their food intake plan. Not knowing this information has an impact on the management of their diet, which is considered a form of medication.

As Americans, we are not educated to be even remotely aware of even the most basic science that underlies the healthcare we access. We are raised to trust that our doctors and pharmacists will manage what we consider the minutiae of the care we receive. But that lack of awareness, paired with a complete lack of care on the part of the pharmaceutical industry, applies to all, including doctors, drug-makers, and dispensers, leaving the patients and their caregivers to figure out the problems they experience after a drug is prescribed, dispensed, and ingested.

As the parent of a highly allergic and Celiac child, I’ve amassed a knowledge that crosses several disciplines: gastroenterology, immunology, and pharmacology, Unfortunately, that knowledge was gained not out of an abundance of curiosity and nerdliness, but out of the necessity that arises after each case of contamination, cross-contamination from the ingestion of allergens included in medications my daughter was prescribed, including medications that were prescribed as a result of a bad allergic reaction to a drug.

The NPR article quotes a gastroenterologist, Dr. Giovanni Traverso, thanks to whom this article was inspired:

“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.””

For some patients, even trace amounts can trigger a life-threatening adverse event. For many, symptoms arising from exposure can last for weeks, even if there was no crisis. The former is what my daughter experiences when there is cross-contamination from dairy or soy, two of the most common allergens found in medicines. The latter is the consequence she suffers with exposure. Weeks of lingering upper respiratory and GI symptoms from one single exposure to a minute dose. Lactose is used to coat the vast majority of pills and is included in many other forms of medications. Soy can be the source of medications, including some of the inhaled medications used by anesthesiologists in the operating room.

Dr. John Kelso, an allergist at the Scripps Clinic in San Diego, has reviewed the issue of allergens in medications. He says reactions are actually quite uncommon. In fact, it’s usually a false alarm.

For example, after many years worrying about the traces of egg protein in flu vaccines, health officials now say that people with egg allergies are not at risk from the shot.

Overreaction to this worry can actually backfire. “Oftentimes the medications are being withheld from patients who say they’re allergic to eggs or soy or something else that may be in the medication,” Kelso says, “but it is actually not a problem.”

This kind of generalization from a so-called expert is what I categorize as the worst kind of malpractice. While, on the surface, Dr. Kelso is relying on the data he collected, we know medical professionals’ awareness of the problem is very low. Were emergency room doctors asked whether they specifically asked patients about allergies and the medications they might have taken prior to having a reaction? Did those doctors record the visit as being due to an adverse reaction to a drug? It is highly unlikely that the research he did is so accurate as to give him a basis for making the blanket determination that egg or soy in a medication isn’t enough to trigger a reaction. Allergies are highly individual and diverse in their nature and sensitivity. What’s more, childhood allergies can reappear later in life, or remain, but at different levels of sensitivity. Some allergies are immediate or delayed, while others are a matter of continued exposure to a particular allergen until the person experiences a serious reaction. So, this type of reductionism is dangerous, especially at a time when Epipens are so expensive as to be out of the reach of many whose lives depend on them.

Different manufacturers of the same medicine often use different inactive ingredients, so if one drug might be causing trouble, it’s worth considering a switch to the same product produced by a different manufacturer, Traverso says.

It has not been our luck to find different manufactures that omit offending allergens. The use of lactose in pills is ubiquitous. The use of corn and soy in their myriad forms, for different uses, is also ubiquitous. Those are the hardest three substances to avoid when you are allergic. They’re in cosmetics, food, and medicines.

According to the article, Dr. Traverso is thinking of producing a tool to help doctors cross-check patient allergies with drug ingredients. It’s a great idea. But the number of accidental prescriptions, ingestions and subsequent illnesses will come down considerably when there is a mass-education effort and public awareness of the need to check all labels, including prescriptions and over the counter medications for allergens, the misery and danger will remain pretty much as they are. People, doctors included, can’t check for something they don’t even know to think about. Until then, a very useful site for allergy sufferers to consult is RxList.

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