Frequently Asked Questions About Gout

frequently asked questions about gout

Learning everything you can about gout may help you to feel more in control of the disease and make more informed decisions about your care. Read on to get the answers to some frequently asked questions about gout.

 

What is gout?

Gout is a form of inflammatory arthritis that is caused by a buildup of uric acid in the bloodstream.1 When the uric acid level remains high for a long time, crystals can form around the joints and cause episodes of sudden and excruciating pain.1 These episodes are known as “flares” or “attacks.” For many people, the first joint affected by gout is in the big toe.1 However, gout flares can also occur elsewhere in the body including the ankles, knees, elbows, wrists and fingers.1

 

Who is affected by gout?

More than eight million Americans are affected by gout—about six million men and two million women.2 Men are typically diagnosed in their late 40s and 50s.3 Women tend to develop gout after menopause.3

 

What are the risk factors for gout?

Aside from gender and age, the risk factors for gout include:

  • Heredity—Recent research suggests that genetics may have a greater impact on gout risk than diet.4
  • Medications—These may include diuretics, salicylate-containing drugs (such as aspirin), niacin (also known as Vitamin B3 or nicotinic acid), cyclosporine (used to suppress the immune system after an organ transplant) and Levodopa (used to treat Parkinson’s disease).5
  • Medical conditions—Untreated blood pressure, diabetes, metabolic syndrome and heart and kidney diseases all can raise your risk of gout.1
  • Recent surgery or trauma—Your risk of gout goes up if you have recently had surgery or experienced some sort of trauma.1
  • Diet—Certain foods and beverages including meat, certain types of seafood, sweets, juices and alcoholic beverages have been shown to raise your risk of gout.1 Fasting and/or “crash” dieting has been shown to increase your risk as well.1
  • Obesity—People who are overweight tend to produce more uric acid.1 This excess uric acid may increase the risk of gout.1

 

How is gout diagnosed?

To rule out other conditions, your doctor will probably examine you and ask you about your symptoms and lifestyle. Your doctor may also perform one or more of these tests:

  • Joint fluid test5
  • Blood test5
  • X-ray5
  • Musculoskeletal ultrasound5
  • Dual energy CT scan5
  • Urine test6

 

What causes a gout flare?

Though a gout attack may seem sudden, chances are it is the result of months or even years of uric acid buildup.7 When the uric acid level in the body remains high over time, urate crystals can slowly form in the joints.7 Eventually, these crystals can cause irritation and trigger an immune response that results in the inflammation, swelling, and intense pain known as a gout flare.7

 

Can gout flares be prevented?

If you have been diagnosed with gout, your doctor may have prescribed you a urate-lowering therapy (ULT) such as allopurinol.8 Allopurinol can help prevent gout flares because it slows down uric acid production in the body.8

If you take allopurinol, your doctor may also prescribe colchicine. is the active ingredient in a medication called Mitigare® (Colchicine) 0.6 mg Capsules, which is specifically indicated for the prevention of gout flares in adults.9 Colchicine is also available in generic form as Authorized Generic Colchicine 0.6 mg Capsules.

 

What could happen if gout is ignored?

Without the right treatment, gout can cause permanent bone, joint and tissue damage.10 Uric acid levels that remain higher than normal have also been linked to other health problems including kidney stones and chronic kidney disease, diabetes, heart attack and stroke.10

Untreated gout can have other effects as well. Research shows that the disease can also take its toll on emotional health, social interactions, sleep and sexual function.11

 

What should I do if I think I have gout?

Although gout is a serious disease, just 10 percent of the people who suffer with it get the treatment they need.12 If you think you have gout, make an appointment to see your doctor as soon as possible. You may also want to download and complete the Gout Flare Questionnaire (from Resources for Patients) before your appointment.

 

Important Safety Information

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®.

Please see the full Prescribing Information and Medication Guide for Mitigare® for complete product details.

 

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.

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References

  1. Gout/Symptoms & causes. Mayo Clinic website. Available at: https://www.mayoclinic.org/diseases-conditions/gout/symptoms-causes/syc-20372897. Accessed 6/22/19.
  2. Zhu Y et al. Prevalence of Gout and Hyperuricemia in the US General Population. The National Health and Nutrition Examination Survey 2007–2008. Arthritis Rheum. 2011;63(10):3136–3141.
  3. Dirken-Heukensfeldt KJ, Teunissen T, van de Lisdonk E, Lagro-Janssen A. “Clinical features of women with gout arthritis.” A systematic review. Clin Rheumatol. 2010;29:575-582.
  4. Nicola Dalbeth and Keith J Petrie: It’s time to change the name of gout. The British Medical Journal Opinion/Comment and opinion from the BMJ’s international community of readers, authors, and editors. Available at: https://blogs.bmj.com/bmj/2018/02/05/nicola-dalbeth-and-keith-j-petrie-its-time-to-change-the-name-of-gout/. Accessed 6/22/19.
  5. Gout/Diagnosis & treatment. Mayo Clinic Website. Available at: https://www.mayoclinic.org/diseases-conditions/gout/diagnosis-treatment/drc-20372903. Accessed 6/22/19.
  6. Gout. NIH Medline Plus website. Available at: https://medlineplus.gov/ency/article/000422.htm. Accessed 6/19/19.
  7. Gout: Joint pain and more. Harvard Health Publishing/Harvard Medical School website. Available at: https://www.health.harvard.edu/pain/gout-joint-pain-and-more. Accessed 6/22/19.
  8. Allopurinol Tablets, USP [prescribing information]. Memphis, TN: Northstar Healthcare Holdings; 2016.
  9. Mitigare® (colchicine) capsules [prescribing information]. Columbus, OH: West-Ward Columbus, Inc.; 2019.
  10. Harris MD, Siegel LB, Alloway JA. Gout and Hyperuricemia. Am Fam Physician. 1999;59(4):925–934.
  11. Singh JA. The impact of gout on patient’s lives: a study of African-American and Caucasian men and women with gout. Arthritis Res Ther. 2014;16:R132.
  12. What Is Gout? Gout Education Society website. Available at: https://gouteducation.org/what-is-gout/. Accessed 6/22/19.

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.