Medication Recall Alert

May 2, 2007

ISSUE:	FDA announces recall of compounded injectable colchicine produced by a compounding pharmacy, ApothéCure, that has been attributed to patient deaths
MEDICATION:	post-manufactured compounded injectable colchicine

The following was excerpted from the FDA Med Watch alert website dated May 2, 2007:
"ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine 0.5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product for return to the company."

The letter dated April 30, 2007 by ApothéCure is included below:

"Recent deaths have been reported in connection with compounded Injectable Colchicine .5mg/ml, 4ml vials, lot number 20070122@26. As a result, ApothéCure is issuing an immediate drug recall at the request of the Texas State Board of Pharmacy for all strengths, sizes and lots of compounded Injectable Colchicine that we have sold in the last year. Since Colchicine is an unpredictable drug, and when not used properly or without adequate testing can cause grave results, we stand firmly behind this recall.

Please examine your drug stocks immediately to see if you have any ApothéCure compounded Colchicine on hand. If so, please discontinue use immediately and promptly report to us the quantities and lot numbers you have in your possession so we can issue a call tag to retrieve the product and credit your account. You will receive an in-store credit on your account to be used on future purchases.

Please return the enclosed card immediately providing the requested information.

This recall is being made with the knowledge of the US Food and Drug Administration.

We appreciate your assistance in this matter. If you have any questions or concerns, please contact one of our pharmacists at 800-969-6601."

RxAmerica's Clinical Analysis of recall impact:

Colchicine is not available commercially as an injectable dosage form and has to be specially ordered and extemporaneously manufactured by a compounding pharmacy. This is done by dissolving powdered colchicine in a compatible liquid and sterile filtering for human use. In this particular formulation, it is often used for off-labeled indications such as back and neck pain. There is recent history of similar deaths and recalls due to non-compliance with Good Manufacturing Practice by the compounding pharmacy. In this instance, the initial evidence indicates that the patient deaths are associated with an excessive concentration compounded at ten times the labeled value. From a managed care perspective, injectable colchicine has very limited and specialized use and not likely approved by and paid through a plan's pharmacy benefit. If you have a specific question about your plan, please contact a member of your account management team.