What You Need to Know About Dietary Supplements

dietary supplements

Congress passed the Dietary Supplement Health Education Act (DSHEA) in 1994.1 Since then, the dietary supplement industry has grown from a $4 billion into a $40 billion business.1 Not surprisingly, a 2019 study revealed that supplements are taken regularly by three out of every four American adults.1 If you use these kinds of products, read on to find out what you need to know about dietary supplements. 

 

What are dietary supplements?

A supplement is a product that contains vitamins, minerals, herbs (or other plant products), amino acids, enzymes and/or other ingredients.2 They are available in a variety of forms, including tablets, capsules, gummies, liquids, powders and bars.2,3 Most dietary supplements can be purchased over the counter.3

 

What are the benefits of vitamins and supplements?

Some supplements can help you get the vital nutrients you may not get if you don’t eat a healthy diet.3 Others may help reduce your risk of disease.3 As easy as it may sound to get essential nutrients from a pill, however, supplements don’t necessarily guarantee better health.4 In fact, some may be dangerous, especially when taken in larger doses than recommended (Vitamin A, Vitamin D and iron, for example3).4

 

What are the risks of dietary supplements?

Some supplements contain active ingredients that can have strong effects on the body and therefore may not be safe for everyone.3 For example, certain supplements can increase your risk of bleeding.2 Others can affect how you respond to anesthesia.2 It is also important to note that combining supplements, using them with other medicines (prescription or over-the-counter) or substituting supplements for prescription medicines can be risky.3

 

How do I know a dietary supplement is safe?

Some dietary supplements are well understood and established.3 Others, however, lack data and need further study.3 It is important to understand that the US Food and Drug Administration (FDA) is not authorized to review dietary supplements for safety and effectiveness before they are marketed.3 Therefore, some supplements may be not backed by scientific evidence.2 You should also know that the FDA will not allow supplements to be marketed for the purpose of treating or curing disease.3 Therefore, a supplement’s claims to lower cholesterol, treat heart disease or cleanse the body of toxins, for example, may not necessarily be true.3

 

Where can I get more information about a supplement?

Carefully read the label and packaging.3 If you still have questions, contact the manufacturer (supplement labels are required to include the name and location of the manufacturer or distributor).3 You can also contact the company and request information that supports the claims made by the product, as well as data on the safety and effectiveness of its ingredients.3

 

What should I do before I start taking dietary supplements?

Although you can buy them over the counter, some supplements may affect the other medicines you take.3 Always tell your doctor about any supplement you’re taking, even if it’s just a multivitamin.3 And always watch for unexpected or unexplained side effects, especially when taking a new product.2

 

What else should I keep in mind about supplements?

If a supplement makes a claim that sounds too good to be true, it probably is.3 Be wary of supplements that claim to be more effective than a prescription drug, “totally safe” or “free of side effects.”3 And keep in mind that “natural” does not necessarily mean “safe.”2,3

 

What should I do if I have a bad reaction to a supplement?

If you believe that a dietary supplement caused you (or a loved one) to become sick or have a serious reaction (even if you aren’t sure the product was the cause), be sure to do the following3:

  1. Stop using the supplement
  2. Contact your doctor for advice
  3. Notify the FDA by visiting https://www.fda.gov/medwatch or calling 1-800-FDA-1088

 

NOTE: This article was not written by a medical professional and is not intended to substitute for the guidance of a physician. These are not Hikma’s recommendations for gout flare prevention, but rather facts and data collected from various reliable medical sources. For a full list of resources and their attributing links, see below.

References

  1. Sancar F. Oversight of Supplements. JAMA. 2019;321(11):1042.
  2. Dietary Supplements: What You Need to Know. National Institutes of Health/Office of Dietary Supplements website. Available at: >. Accessed February 19, 2020.
  3. What You Need to Know about Dietary Supplements. US Food and Drug Administration website. Available at: https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements. Accessed February 19, 2020.
  4. Dietary supplements: Do they help or hurt? Harvard Health Publishing/Harvard Medical School website. Available at: >. Accessed February 19, 2020.

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.
  • Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.
  • Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
  • Drug interaction with dual P-gp and CYP3A4 inhibitors: Co-administration of colchicine with dual P-gp and CYP3A4 inhibitors has resulted in life-threatening interactions and death.
  • Neuromuscular toxicity and rhabdomyolysis may occur with chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (including those with normal renal and hepatic function) are at increased risk. Consider temporary interruption or discontinuation of Mitigare®.
  • The most commonly reported adverse reactions with colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal pain.

Indication

Mitigare® is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied.

Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.

For Full Prescribing Information please CLICK HERE and for Medication Guide CLICK HERE.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228

Important Safety Information for Mitigare® (colchicine) 0.6 mg capsules

  • Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4. Combining these dual inhibitors with colchicine in patients with renal or hepatic impairment has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not be given Mitigare®.
  • Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children.