Warning on Colistimethate for Inhalation

FDA is investigating a patient death that may be associated with the inhalation of the antibiotic colistimethate, or Coly-Mycin M. This drug is used to treat serious infections due to Gram-negative bacteria, particularly Pseudomonas aeruginosa. It is approved only for intravenous or intramuscular injection, but some practitioners prescribe it off-label as a solution to be inhaled from a nebulizer. The solution is prepared by mixing the drug with sterile water or saline just prior to inhalation.

Colistimethate is a pro-drug that is inactive in its dry state. When mixed with water, it undergoes spontaneous hydrolysis to the bioactive form, colistin, which may cause pulmonary inflammation. Storing the pre-mixed colistimethate solution for longer than 24 hours results in increased concentrations of colistin, and this may increase the potential for lung toxicity.

In the case FDA is investigating, a cystic fibrosis patient had a home nebulizer treatment with a colistimethate solution that had been pre-mixed by a pharmacy. The patient developed acute respiratory failure and later died.

There are three important precautions that may help to prevent this kind of toxicity:

• First, if you choose to prescribe colistimethate for inhalation, avoid pre-mixed, ready-to-use solutions.

• Second, instruct patients and caregivers to administer the solution promptly after it's mixed.

• Finally, instruct patients who may have supplies of the pre-mixed form to discard them.

FDA Patient Safety News: September 2007

For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=67#1

Category:

News & Politics

Tags:

• Coly-Mycin
• M
• nebulizer
• Pseudomonas
• aeruginosa
• cystic
• fibrosis
• FDA
• Patient
• Safety
• News

[sp4de69]

@feanor607 Wow, you have no idea how similar our stories are

[feanor607]

God I wish that I could be treated by THIS guy. I've had pseudomonas in my lungs since I received infected IVs and I've been on nebulised Colomycin for years and the infcetion just gets worse. NOBODY reviews it or offers anything different. I KNOW that it will kill me but the NHS in the UK CARES NOT