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  • Mar 26, 2019

Since our clients are facing risks and high costs associated with liver injury and chronic kidney disease, we wanted to compile some information pertaining to the impact of over-the-counter (OTC) medications and herbal and dietary supplements (HDS) in these areas. We believe this information will help drive a more proactive approach that better educates and protects employees, members and patients from these often devastating and potentially costly conditions. Particularly when these OTC medications or supplements are mixed with prescriptive drugs, contraindicated in certain health conditions, known to adversely injure certain organs when taken in quantity over time, or combined with foods or drinks that potentiate their effect.

Drug Induced Liver Injury (DILI)

Drug Induced Liver Injury, or DILI, is a liver injury caused by an adverse reaction to certain drugs and herbal products. “Over 1,000 medications and herbal products have been implicated in the development of drug-induced liver injury (DILI), and the list continues to grow.

“The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Drug-Induced Liver Injury Network (DILIN) to collect and analyze cases of severe liver injury caused by prescription drugs, over-the-counter drugs, and alternative medicines, such as herbal products and supplements.”

The National Institutes of Health maintains a searchable database of drugs, herbal medications, and dietary supplements that have been associated with DILI. A handy reference tool.

Over the counter (OTC) medications have long been a staple in our modern, fast-paced American society. We have collectively trusted OTC medications to be a more convenient, “safe” and less expensive alternative to more costly prescription medications. Yet, there is growing evidence of OTC medications leading to serious health complications and related costs.

Over the Counter simply means that a healthcare professional’s prescription is not required to purchase the drug. This makes them a convenient option for consumers seeking quick relief.

The dangers of OTC drugs are easily and often overlooked in favor of convenience and cost. There is an unfortunate misconception regarding the safety of OTC drugs perpetuated by a lack of information as it pertains to their intended use. For example, acetaminophen, the most common drug ingredient in America, is widely used to reduce fever and pain reliever, and is included in hundreds of prescription and OTC medications.

According to the U.S. National Institutes of Health's National Library of Medicine (NIH/NLM): “When used according to label directions, it has an established record of safety and efficacy. However, acetaminophen is a leading cause of drug toxicity that may lead to serious liver damage and death when the patient exceeds the maximum daily dose. The Food and Drug Administration (FDA) has worked for several years to address the safety of acetaminophen.”

According to KnowYourDose.org – “Exceeding the maximum daily dose of 4,000 mg is an overdose and can lead to liver damage. Of those who exceed 4,000 mg in one day, most do so by: Taking the next dose too soon; Using multiple products containing acetaminophen; Taking too much at one time.”

The NIH/NLM states that another dangerous and insidious threat to liver and kidney health are herbal and dietary supplements (HDS) – including some body building agents / steroids, green tea extracts and other multi-ingredient nutritional supplements. HDS-induced liver injury now accounts for 20% of cases of hepatotoxicity in the United States based on research data.

Some cases are severe enough to require organ transplants, while other cases progress beyond control and are ultimately terminal. Fortunately, damage caused by herbal and dietary supplements can be treated, prior to reaching a critical stage, with appropriate intervention.

Because herbal and dietary supplements are not FDA regulated, the harmful side effects may not be labeled. This perpetuates the notion that herbal and dietary supplements are harmless, or even as pure as the label indicates, when they may contain fillers to pare down the manufacturer’s expense.

Fish oil is a good example of a popular OTC product that has been cited for uneven quality by WebMD because it is less effective when not wild, and is often stretched with non-fish oil filler or contaminants when farm raised. Situations like this make education, “buyer beware” label reading and product research a critical component in addressing associated risks.

A great amount of press has also been associated with harmful OTC weight loss preparations and those relieving depression, stress or anxiety.

Chronic Kidney Disease

Nonsteroidal anti-inflammatory drugs (NSAIDs) are yet another type of fever and pain reducing OTC drugs, which include but are not limited to aspirin, ibuprofen, ketoprofen and naproxen. People take them for a variety reasons, with some taking larger doses because they believe a higher dose will provide more immediate relief.

According to a Centers for Disease Control (CDC) Expert Commentary: “People with chronic kidney disease are generally advised not to take NSAIDs, with the exception of aspirin (for cardiovascular indications). NSAIDs have been associated with acute kidney injury in the general population and with progression of disease in those with chronic kidney disease. NSAIDs may also decrease the effectiveness of certain prescription medications that are often used by people with kidney disease, such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and loop diuretics. Yet new research shows that people with chronic kidney disease, including people with moderate-to-severe kidney disease, are continuing to use NSAIDs at the same rate as the general population.”

Only the patient can control what he or she puts into their body. To support more-informed decision-making in these areas, education on potential dangers of OTC drugs and herbal and dietary supplements, adverse effects of certain combinations and quantity limits is important for individuals at risk of kidney or liver damage from overuse. For example, OTC medications that contain NSAIDs reduce blood flow to the kidney, decreasing function. Higher dosages taken for an extended period can also harm even healthy kidneys.

Exacerbating the confusion, some medications contain a combination of painkilling ingredients such as aspirin and acetaminophen. Also, painkilling ingredients can be found in somewhat unexpected places – such as in cough syrups or sleep aids – leading to accidental overdose. This complex medication landscape requires much diligence on the part of the end-consumers as well as their providers.

Criticality of Understanding The Full Patient Picture

Feeding into the overall risk with DILI and CKD is the fact that these OTC medications and herbal supplements are easily overlooked by both the patient and the physician during office visits – often with devastating consequences.

To minimize risks, it is crucial that providers fully understand each patient’s health history and are aware of all medications and herbal and dietary supplements that the patient consumes. To have a more complete understanding of the health risks threatening patient health outcomes, providers should also ask patients the quantity and frequency of their OTC medication and supplement use.

For providers, it’s also critical to identify individuals who are suffering from CKD, DILI, Heart Disease or any other condition that can be negatively impacted through improper OTC and herbal supplement use and / or concomitant use of prescriptive medications or foods and drinks with which they interact, so that they may be appropriately educated and monitored.


The Advanced Plan for Health longitudinal and predictive analytics platform, Poindexter, supports the identification of those with chronic conditions mentioned here (current state and predictive), and also can help paint a fuller picture of prescription medications that a patient is taking. Knowing this, along with the details of health conditions, care gaps and compliance, treatment history, OTC medications and herbal and dietary supplements taken can help reduce risks and avoid negative downstream impact.

Click here to schedule time to discuss your needs, and to learn more about how our advanced and predictive analytics are helping clients to bend the medical cost trend while keeping quality high.