CF Death Prompts FDA Alert on Nebulized Liquid Colisthemethate

ROCKVILLE, Md., June 29 --The death of cystic fibrosis patient had led the FDA to alert physicians about the risk of prescribing premixed colistimethate for inhalation with a nebulizer.

Premixed colistimethate is not approved for inhalation with a nebulizer, the FDA pointed out. Whern colistimethate is premixed and used in a nebulizer it breaks down into its component chemicals, some of which are harmful to the lungs.

Premixed colistimethate is approved for intravenous or intramuscular injection. The drug is used to treat infections caused by certain bacteria, including Pseudomonas aeruginosa, known to cause serious lung infections in patients with cystic fibrosis.

In light of the patient's death, the FDA said:

• If using the liquid form in a nebulizer, it should be used promptly after being mixed.
• Patients should discard any unused premixed liquid form of colistimethate.
• Physicians who use colistimethate to treat patients with cystic fibrosis should be aware of the potential for serious and life threatening side effects from inhalation of pre-mixed, ready-to-use liquid forms of colistimethate.