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Is the FDA Biased Against Dietary Supplements?

Why do health professionals and FDA officials seemingly downplay the dangers of drugs while warning people about dietary supplements? It's a mystery to us.

Will your vitamins or dietary supplements hurt you? Millions of Americans take multivitamins, herbs or other supplements every day. Most people don’t worry about possible dangers from these pills.

Many health professionals, on the other hand, warn that dietary supplements could send you to an early grave. The FDA often cautions about the risks of taking supplements.

While high doses of some vitamins or minerals could certainly be harmful, they rarely cause life-threatening reactions. Prescription and over-the-counter drugs, on the other hand, might cause serious complications or even death. Public health authorities rarely warn about dangers associated with OTC medications.

The Strange Anti-Supplement Bias:

If a vitamin, herb or other supplement caused hypertension, heart attacks, strokes, bleeding ulcers and kidney disease, there would be headlines in newspapers. Physicians would demand that the product be pulled off the market. The Food and Drug Administration would likely send out a dire alert warning the public to immediately stop taking the dangerous dietary supplement.

NSAIDs Can Be Killers:

Yet millions of people take nonsteroidal anti-inflammatory drugs (NSAIDs) daily without a second thought. The OTC label is often hard to read because of tiny print. About the only side effects mentioned are allergic reactions and stomach bleeding.

Doctors frequently prescribe drugs such as diclofenac, ibuprofen, meloxicam, naproxen and piroxicam without warning their patients about all the potential side effects. These pain relievers can trigger hypertension, fluid retention, heart attacks, strokes, atrial fibrillation, congestive heart failure, severe allergic reactions, bleeding ulcers, kidney damage and liver damage. Any of these could be fatal.

The Double Whammy from PPIs:

Because NSAIDs can be irritating to the digestive tract, it is not unusual for people on such medicines to be prescribed heartburn medicine. Proton pump inhibitors (PPIs) to treat heartburn are among the most popular drugs in the pharmacy. There are even medications that combine an NSAID with a PPI. That is supposed to make it easy for people who have to take pain relievers to protect their digestive tracks with one pill.

Medications such as omeprazole (Prilosec), lansoprazole (Prevacid) and pantoprazole (Protonix) were originally developed to treat severe gastroesophageal reflux disease (GERD). But they are so good at alleviating the pain of reflux that doctors were soon prescribing them for all sorts of digestive distress.

At first, PPIs were considered pretty innocuous. The FDA decided they were so safe, in fact, that no prescription was necessary. You can find OTC esomeprazole (Nexium 24HR), lansoprazole or omeprazole.

PPIs and the Cardiovascular System:

According to Danish scientists, though, PPIs are associated with an increased risk of stroke. These investigators reviewed the medical records of almost a quarter million Danes and told the doctors attending the recent American Heart Association meetings that people taking a PPI were more likely to experience a stroke than those not taking an acid-suppressing drug.

Last year, researchers found that PPI users were 16 percent more likely to have heart attacks (PLOS One, June 10, 2015) than nonusers.  Other drugs used to treat heartburn (cimetidine, famotidine, ranitidine) had no such association.

The PPI and NSAID Combination:

Think about this for a moment. NSAIDs increase the risk for heart attacks and strokes. Some researchers have gone so far as to encourage their medical colleagues to avoid prescribing drugs like diclofenac, ibuprofen, meloxicam or naproxen to people who have had heart attacks because of the increased risk for triggering another one.

Because NSADs irritate the stomach, though, doctors frequently prescribe PPIs to prevent irritation or ulcers. The only trouble is that now we know PPIs may also increase the risk for heart attacks and strokes. It is entirely possible that taking two different kinds of medicines (NSAIDs and PPIs), each of which poses cardiovascular challenges, that patients will be at even greater risk of a heart attack or stroke on the dual drugs.

To the best of our knowledge, no one has bothered to ask this question before and no research has been undertaken to determine if there is an additive or synergistic elevation in risk. An additive risk would be like 1+1=2. A synergistic risk would be 1+1=3.

Other side effects of proton pump inhibitors include an increased risk for infection, kidney damage, dementia, weakened bones and fractures and blood disorders. Nutrients such as calcium, iron, magnesium, vitamin B12 or zinc may not be well absorbed.

FDA’s Bias Against Food Remedies:

While the FDA seemingly turns a deaf ear to our concerns about the safety of some OTC drugs, it hammers food manufacturers. Take tart cherries as an example. There is a substantial amount of research demonstrating that cherries have anti-inflammatory ingredients that protect against muscle damage and may even ease arthritis pain. The FDA considers any suggestion that tart cherry products could be beneficial as “unauthorized health claims.” In fact, the FDA has written threatening letters to the manufacturers of tart cherry dietary supplements because they suggested that such products might have anti-inflammatory properties:

“Your tart cherry concentrate products are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act…New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the FD&C Act…FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.”

So, as far as the FDA is concerned, tart cherry concentrate dietary supplements are drugs. Any suggestion that such products could be helpful for health would bring down the wrath of the agency. As far as we know, tart cherries do not cause ulcers, hypertension, kidney disease, atrial fibrillation, heart attacks or strokes. And yet the FDA seems so worried about protecting the public health that it can devote valuable resources to going after the manufacturers of such products.

The People’s Pharmacy Bottom Line:

Treating over-the-counter drugs as if they had few, if any, hazards is short sighted. Going after the makers of cherry dietary supplements and calling them drugs seems to us like a waste of tax payer dollars. Perhaps it is time for public health authorities to be more even-handed in their warnings.

If you want to learn more about non-drug approaches to common ailments, we recommend our book, The People’s Pharmacy Quick & Handy Home Remedies. You might be surprised to learn how many foods have healing properties. Here is the link.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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