Many people use dietary supplements on top of or in place of prescription medications to manage their health conditions.
But without strict federal oversight or comprehensive studies, these supplements can sometimes cause serious medical issues.
For one 64-year-old woman who took a red yeast rice supplement to lower her cholesterol, the end result was a trip to the hospital for acute liver injury.
A group of doctors from Michigan described the woman’s case in the journal BMJ Case Reports. They noted that she took the red yeast rice supplement because she was “hesitant to start taking statins.”
Red yeast rice supplements contain monacolin K, ranging from . This compound is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin, which also carries a risk of liver damage.
After using the supplement for six weeks, the woman ended up in the hospital with symptoms including fatigue, bloating, and dark urine.
Her doctors diagnosed her with drug-induced liver injury, with red yeast rice as the likely cause. She was treated with steroids until her condition improved.
Although this is a single patient, it raises questions about the safety of red yeast rice supplements and how well they are regulated in the United States.
Some studies have found that red yeast rice can lower LDL (“bad”) cholesterol — either by itself or with other natural compounds.
Dr. Jay Mohan, a cardiologist at McLaren Macomb Hospital and McLaren Oakland Medical Center in the Detroit area said “it’s very interesting to know that there are other options to statins. But the problem is that the safety profile of red yeast rice is unpredictable.”
Other case reports have identified serious side effects in people who used red yeast rice.
However, one review of previous research found that most people tolerated red yeast rice.
The authors point out that clinical studies use high-quality red yeast rice. The issue is what you buy online or in the store may not live up to those precise standards.
In the United States, supplements don’t have to undergo the same clinical testing as prescription drugs to show that they are safe and effective.
And companies that make supplements don’t have to follow the same strict manufacturing rules as pharmaceutical companies.
This may change in the future. The U.S. Food and Drug Administration recently announced that it will strengthen its oversight of the dietary supplement industry.
But right now, this lack of oversight means that a red yeast rice supplement from one company may have much higher amounts of the active ingredient monacolin K. It may also have other compounds that cause side effects or interact with prescription medications.
“You don’t know how much of an ingredient you have in each pill,” said Dr. Colin Zhu, a traveling physician who specializes in family practice, lifestyle medicine, and culinary medicine.
“On top of that,” said Zhu, “you don’t know where the company gets the ingredients from, or what kind of quality control they have, in terms of processing and manufacturing.”
The BMJ Case Reports article brings home the point that “natural” doesn’t always mean “safe.”
“The fact that the patient developed drug-induced liver injury from taking a supplement like this is very concerning,” said Mohan, “because that could be a life-threatening illness.”
Mohan said it would be difficult for many cardiologists to recommend a red yeast rice supplement over statins, because statins are an important part of how they treat patients with high cholesterol.
Statins also have years of clinical trials behind them showing their benefits. The research behind red yeast rice is less extensive.
Of course, statins have their own side effects, including muscle-related issues, new-onset diabetes, and an increased risk of stroke.
But 85 to 90 percent of people report no side effects from these drugs, according to the American College of Cardiology.
“The statin medications we have today are so well-tolerated, and they’ve been so extensively tested, that I rarely have patients that need to be taken off these medications,” said Mohan.
Doctors also follow up with patients after they start taking a statin to see how well they are tolerating it. This includes checking their blood levels for problems related to the drug.
This ongoing monitoring piece is missing when people self-treat using dietary supplements, especially when they don’t talk with their doctor about what they’re taking.
Zhu said he doesn’t recommend that patients self-treat with supplements, although he admits that many people already do.
One recent estimates that over half of Americans took at least one dietary supplement over the past 30 days.
Also, according to Consumer Reports, Americans spent about $49 million on red yeast rice supplements in 2015.
Mohan said he encourages patients to let him know if they don’t want to take a medication he has prescribed. And to talk to him about supplements they are taking.
As for red yeast rice supplement? He would be open to a patient trying it.
“But I would let them know the risks,” said Mohan. “And I would also tell them that this supplement isn’t shown to have the same beneficial effects as statins, which it is meant to replace.”
Zhu agrees that it is important for people to talk with their primary care provider about what supplements they are taking.
“But it’s not just about supplementing. It’s about finding the root cause of disease,” said Zhu. “If there’s a reason why you’re supplementing, that needs to be clarified with your primary care provider.”