Colchicine - "Recall" by FDA Prompted by 23 Deaths - Lawyer Fred Pritzker Representing One of the Families

Injectable colchicine may be responsible for 23 deaths. Three of the deaths from intravenous colchicine occurred in March and April of 2007 and were associated with the use of compounded colchicine that, due to an error in preparation, was eight times more potent than the amount stated on the label. Our law firm is representing the family of one of these three people. Partner Fred Pritzker is lead attorney in this case. To contact Fred Pritzker, please call him toll-free at 1-888-377-8900 or submit the free case consultation form for his review.

Syringe On February 6, 2008, the U.S. Food and Drug Administration (FDA) announced its intention to take enforcement action against companies marketing unapproved injectable colchicines. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.

"Today's action [the equivalent of a colchicine recall] supports our ongoing efforts to end the marketing of unapproved drugs with serious health risks," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "Such products put consumers' health and sometimes their very lives at grave risk. It is a priority that these products be removed from the market."

"Until recently, there was one manufacturer of unapproved injectable colchicine, and that firm has ceased manufacturing the product," said Deborah Autor, director of the FDA's Office of Compliance, CDER. "This serves as the agency's warning that firms wishing to make injectable colchicine in the future must not manufacture the product until they apply for and are granted approval by the FDA to do so."

In addition to being manufactured by pharmaceutical companies, injectable colchicine products are sometimes formulated on a smaller scale by compounding pharmacies, often for use in the treatment of back pain. The FDA has not approved colchicine in any dosage form for the treatment of back pain.

This action by the FDA could be considered a colchicine recall. Anyone who has been injured by injectable colchicine should contact a lawyer. If a family member has died after being given colchicine, you may have a wrongful death claim. Please contact our law office for a free consultation.

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