The FDA Takes Action Against Unapproved use of Colchicine a Drug used to Treat Gout

By February 6, 2008Drug Safety

Colchicine is a drug used to treat gout which frequently results in inflammation of the joints in the fingers and toes. Last week, the U.S. Food and Drug Administration announced it would go after companies marketing unapproved uses for the injectable gout drug, Colchicine.
Colchicine is a highly toxic drug that can easily be administered in excessive, toxic doses. The FDA indicated that it has received 50 reports of adverse events associated with the use of the drug, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.
Injectable colchicine is sometimes used to treat back pain. Three of the reported deaths 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. The FDA has not approved colchicine for the treatment of back pain.
The enforcement action means that individuals and companies must stop making the product within 30 days and stop shipping the product within 180 days or face regulatory action which could include seizure, injunction or other legal action deemed appropriate by the agency.
The FDA’s action does not affect tablet form colchicine which is frequently used to prevent gout attacks.
The lawyers of Carey, Danis & Lowe are experienced in helping people injured by a dangerous prescription drug. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.
We offer a free initial consultation for victims of dangerous medications. If you cannot make it to our office, we will come to you at the hospital or your home.
Contact the lawyers at Carey, Danis & Lowe today by calling 877-678-3400.