Pre-made Colistimethate May Link to Cystic Fibrosis Patient's Death

The FDA has received a report about the death of a patient with cystic fibrosis (CF) who used the antibiotic Colistimethate that had been premixed by a pharmacy into a liquid for inhalation with a nebulizer. A nebulizer is a device that turns liquid medicine into a mist which is breathed in by patients to deliver the medication directly to their lungs. Nebulizers are commonly used by patients with CF. The Colistimethate that was used by this patient had been prepared and dispensed by the pharmacy as a ready-to-use liquid.

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 via nebulizer. When Colistimethate is mixed into a liquid form, the product begins to break down into other chemicals that can damage lung tissue. Colistimethate is used to treat infections caused by certain types of bacteria, including the bacteria Pseudomonas aeruginosa, a germ that is known to cause serious lung infections in patients with CF.

In light of this reported patient death, FDA offers the following recommendations:

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