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February 6, 2008 FDA NEWS ALERT: Colchicine Side Effects & Deaths

The FDA has stated it decision to take enforcement action against any company marketing injectable Colchicine that is unapproved. Anextremely toxic drug, Colchicine is used to treat gout and can very easily be given in excessive doses, resulting in serious side effects, low blood counts, organ failure, cardiac events and even death.

The FDA has received 50 reports of events involving injectable Colchicine, 23 of which resulted in death.

The FDA states, “Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.”

------------END OF Colchicine FDA Alert for Feb 6 2008---------------

Colchicine is a nitrogen-based and highly toxic chemical that doctors use to relieve a number of extremely painful and debilitating physical conditions such as:

  • Gout: Gout is a condition that causes uric acid to build up in the cartilage of joints and tendons, causing extremely painful inflamed tissues.  Colchicine gout treatment side effects are a potential consequence of this condition.
  • Familial Mediterranean fever:  This systemic inflammatory disorder primarily affects people with roots around the Mediterranean, and affects a wide range areas including abdominal problems, joint problems, and chest problems
  • Secondary amyloidosis(AA): An imbalance of protein concentrations
  • Scleroderma: A disease caused by excessive collagen in the organs or skin

On April 30th, 2007, the Food and Drug Administration, in conjunction with drug manufacturer ApothéCure, have issued an immediate drug recall for compounded Injectable Colchicine .5mg/ml, 4ml vials, lot number 20070122@26 due to a number of deaths associated with the product.  Colchicine poisoning is a likely consequence of mislabeled drugs.

The Texas State Board of Pharmacy recalled all strengths, sizes and lots of compounded Injectable Colchicine because of the unpredictability of the drug.   Colchicine is extremely dangerous when not tested or used properly, and recent reports from Texas allege that this lot of Colchicine was made stronger than indicated on the label.  This recall is a similar to a Class I recall issued in December 2000, when Phyne Pharmaceuticals of Scottsdale, Arizona alerted the healthcare community that their Colchicine doses were mislabeled as .5 mg/mL, but was actually 5 mg/mL.

There is no antidote for Colchicine.  There have already been fatalities in Oregon and Texas.  Other side effects of Colchicine include:

  • Fatigue
  • Weakness
  • Sore throat
  • Rash
  • Numbness
  • Allergic reactions such as hives, swelling of lips/face/tongue, closing of throat, difficulty breathing
  • Unsuspected bleeding and brusing
  • More serious Colchicine side effects include fetal damage in pregnant women anemia, and even death.

If you or someone you know was affected by the ApotheCure colchicine recall you should contact a defective drug attorney immediately.  You may be entitled to financial compensation if you have suffered any loss, but if you hesitate the statute of limitations in your state puts time restrictions on how long you can take action.  Let our dedicated and aggressive lawyers take your case.  Contact us today.

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If you've been injured from taking ApothCure Colchicine, please contact us for free case review. Page updated for FDA Alert on Colchicine 2/6/2008.