Colistimethate (Coly-Mycin M®, generics) Inhalation Possibly Associated With Death
July 2, 2007
The FDA issued a warning regarding the possible association between premixed colistimethate (Coly-Mycin M®, generics) for nebulization and the death of a patient with cystic fibrosis (CF). Colistimethate is approved for intramuscular or intravenous injection to treat susceptible isolates of Gram negative rods, especially Pseudomonas aeruginosa. Colistimethate is not approved as a nebulized agent, but is often mixed just prior to use in CF patients with P. aeruginosa infection.
In the reported case, the drug was compounded into a liquid form and placed in unit dose vials for use as prescribed. Colistimethate is unstable in aqueous solution and undergoes hydrolysis to the active form of the drug, colistin. A component of colistin, polymyxin E1, has the potential to damage lung tissue. To prevent this toxicity, administer colistimethate immediately after preparing.
When prescribing colistimethate for inhalation, be aware of the possibility of life-threatening side effects. Educate patients not to use premixed, ready-to-use, liquid forms of colistimethate inhalation. Additional information is available at the following links:
- FDA MedWatch Alert:
- Information for Healthcare Professionals:
- FDA Public Health Advisory:
July 2, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.