Dietary supplements found tainted with prescription drugs

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The Food and Drug Administration (FDA) found between 2007 and 2016 that 776 dietary supplements from 146 companies contained prescription drugs, some of which pose significant risks to consumers.

Yet the FDA has never issued a mandatory reminder. He announced voluntary reminders – when companies agreed to remove products from store shelves – in less than half of those cases.

These results, based on data from the FDA, were published on October 12 in the journal JAMA Network Open.

Some people are turning to supplements for thinking about finding a safe "natural" alternative to pharmaceuticals, says Chuck Bell, program director at Consumers Union, Consumer Reports' policy and engagement division. "Clearly," he says, "that's not the case.

Here's what you need to know about the new study, the safety of supplements and how the FDA has handled recalls.

The risks of contaminated supplements

Researchers, from California's Department of Public Health, discovered that supplements designed to combat erectile dysfunction, weight loss or bodybuilding were the most likely to be adulterated with unapproved pharmaceutical ingredients.

These contaminants included sildenafil (Viagra and generic), fluoxetine (Prozac and generic), sibutramine (an appetite suppressant removed from the market because of heart attack risk and stroke), some of which 39 have not been approved for human use.

The FDA does not publish the amounts of these ingredients in each supplement, so it's impossible to know exactly how dangerous the additions were. (The FDA also does not indicate how much and what types of supplements it tests each year, note the study's authors.)

Manufacturers can add prescription drugs to supplements to increase their effectiveness, says Pieter Cohen, MD, associate professor of medicine at Harvard Medical School and physician staff member of the Cambridge Health Alliance, whose editorial was published parallel to the new study. Consumers who buy a supplement against erectile dysfunction with added Viagra, for example, may not be aware of what is really behind the results.

"It's a really big problem with potentially devastating medical consequences," Bell says. "Thousands of people visit the emergency room every year because of the detrimental effects of using supplements."

In the past, the authors of the study note, the use of dietary supplements has been associated with adverse effects, including stroke, acute liver injury, kidney failure, pulmonary embolism and death. One study found that the use of dietary supplements was associated with 23,000 emergency visits to the United States each year.

Taking non-prescribed pharmaceuticals can also create risky interactions with existing prescriptions. For example, taking sildenafil with certain medications to treat diabetes, high blood pressure and high cholesterol can lower blood pressure to dangerous levels.

Companies adding pharmaceuticals to their products are "a stain" for the industry, says Duffy MacKay, ND, Executive Vice President of Scientific and Regulatory Affairs at the Center for Responsible Nutrition (CRN), a professional association for the supplement industry. . "We support the vigorous pursuit of supplement companies that include non-advertised drugs in their products."

Why these supplements are still sold

The new study revealed not only that hundreds of supplements are contaminated with potentially dangerous prescription drugs, but also that in 52% of cases, companies did not remember supplements even with known adulterants. And there has been no case where the FDA has issued a mandatory reminder, which the agency is empowered to do since 2011.

In an email, the FDA told Consumer Reports that she "is aware of the study and is reviewing and analyzing its findings". The agency also said that when supplements contain these types of unapproved pharmaceutical ingredients, they are generally excluded from the definition of a dietary supplement and may be subject to regulation as drugs, when "the FDA does not have mandatory reminder authority".

"This study highlights some important gaps in the regulation of FDA supplements," said Cohen. "That it is a problem of limited resources within the agency or a reluctance to implement strict enforcement measures, there is a risk important that is not resolved. "

Voluntary recalls, which occurred in 48% of cases in the new study, were also somewhat ineffective. Supplement reminders are often released to the public through FDA email alerts and publications on the agency's website. However, two recent studies have indicated that supplements recalled due to adulterant pharmaceutical products often continue to be sold and that many consumers were still unaware that these recalls existed.

Security Supplement

Americans spent about $ 42 billion on food supplements in 2017. However, given the weak regulatory environment, it's hard to know exactly what you get when you take one, says Bell. Supplements also do not undergo the same safety and efficacy tests as prescription and over-the-counter medications.

Here are three things to do before taking a supplement.

For more information, see "4 tips for smart and safe use of alternative medicine" in our November 2018 cover story.

Editor's note: This story has been updated to include an FDA response, which CR received after the original publication of the story.

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• Talk to your doctor. Your service provider may make recommendations based on your complete medical history and risk factors, and also consider any potentially troubling interactions with your existing medications. Even uncontaminated supplements can interact dangerously with certain medications.

• Look for a seal, such as "USP Verified" or "NSF". These seals do not indicate that a supplement works as advertised, but they mean that an independent group has checked the quality or purity of the supplement to make sure it contains what it is supposed to contain. (Learn more about these seals and their meaning.)

• Avoid the most dangerous supplements. Review our list of "15 Complementary Ingredients That Should Be Systematically Avoided" and consider providing marketed supplements to help combat erectile dysfunction, weight loss, and bodybuilding, which, according to this study, were the most likely to occur. 39, be contaminated with prescription drugs.

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