Approved by the FDA – Colchicine Medication

On July 30, 2009, the U.S. Food and Drug Administration (FDA) approved Colcrys to treat acute gout pain.  Colcrys contains an active ingredient called colchicine.  Colcrys is a colchicine medication manufactured by Mutual Pharmaceutical Company, Inc.

Colchicine is a complex compound (Colchicum autumnale) which is extracted from the dried seeds of autumn crocus or meadow saffron plants.  Colchicum was first identified in the first century A.D. for having medicinal properties and was first used to treat gout in 1810.

Colchicine  medication has been used by the medical community for many years to treat gout but had not been approved by the FDA.  Although, the FDA did not approve the single-ingredient oral colchicine product, a combination drug containing colchicine was approved in 1939.

Dosage Changes for Colchicine Medication

Physicians usually have prescribed colchicine medication to be taken hourly for acute gout flares until the gout pain subsides.  Unfortunately, many patients experienced gastrointestinal problems. A dosing study that was required by the FDA, demonstrated that one dose initially and a single additional dose after one hour was just as effective, but much less toxic.  As a result of this research, Colcrysis was approved (lower dose) for acute gout attacks.  The FDA has notified physicians about this new dosing regimen and also warned about the potential for severe drug interactions this medication may cause.

Medications That May Cause Interactions With Colchicine Medication:

  • clarithromycin
  • telithromycin
  • cyclosporine
  • ketoconazole
  • itraconazole
  • HIV protease inhibitors
  • nefazodone

Gout is a painful form of arthritis. Gout may occur when uric acid levels in the blood are elevated.  As a result of high uric acid levels (hyperuricemia), urate crystals may form in joints, urinary tract and soft tissues, causing damage.  Because gout is a serious medical condition it should be treated by health care professionals.

Colcrys was also approved for familial Mediterranean fever (FMF), an inherited inflammatory disorder that affects the lining layers of the lungs and abdomen.   As a result of this approval, Colcrys becomes the first drug approved to treat FMF.

Colchicine Medication has been proven to help many people to relieve their gout pain and symptoms.