Colistimethate (marketed as Coly-Mycin M and generic products) - Overview
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Welcome to the Food and Drug Administration's drug safety update.
I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research.
On June 28, 2007 we issued a public health advisory regarding a report we received about the death of a patient with cystic fibrosis who used the antibiotic Colistimethate that had been premixed by a pharmacy into a liquid for inhalation with a nebulizer.
When Colistimethate is mixed into a liquid form, the product begins to break down into other chemicals that can damage lung tissue.
We recommend that if the liquid form of Colistimethate is given through a nebulizer, it should be used promptly after being mixed, and patients should discard any unused pre-mixed liquid form of Colistimethate.
Colistimethate is FDA-approved only for injection into a vein or a muscle; it is not FDA-approved for use as a liquid to be inhaled by a nebulizer.
To hear the full public health advisory, listen to part two of this broadcast.
We urge both healthcare providers and patients to report side effects from medical products to the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot G-O-V slash M-E-D-W-A-T-C-H.
Date created: June 29, 2007, updated July 2, 2007