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Colistimethate (Coly-Mycin M)

A cystic fibrosis patient may have died as a result of using the antibiotic Colistimethate that had been premixed by a pharmacy into a liquid for inhalation with a nebulizer. The FDA has not approved this use for Colistimethate (marketed as Coly-Mycin M and generics). However, in treating CF patients with Pseudomonas infections, colistimethate is often mixed with sterile water to form a solution just prior to inhalation via nebulizer.  After mixing with sterile water and a buffer, colistimethate undergoes spontaneous hydrolysis to the bioactive form colistin.   A component of colistin, polymyxin E1, is toxic to lung tissue.  Premixing colistimethate into an aqueous solution and storing it for longer than 24 hours results in increased concentrations of colistin in solution, increasing the potential for lung toxicity.  Both product liability and malpractice issues may be involved in a Colistimethate lawsuit. 

Lawyer Fred Pritzker, has over 30 years of malpractice and product liability lawsuit experience and has recovered millions for clients.  He is nationally recognized and has been interviewed by the New York Times, Wall Street Journal, and other publications.  In recognition of his accomplishments, he has been selected by other lawyers for inclusion in The Best Lawyers in America.

FDA Colistimethate (Coly-Mycin M) Public Health Advisory
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.  Colistmethate is marketed as Coly-Mycin M and generics. 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:

  • If using the liquid form in a nebulizer, it should be used promptly after being mixed.
  • Patients should discard any unused pre-mixed liquid form of Colistimethate. [This is the FDA recommendation.  Pritzker | Ruohonen recommends not using it and keeping it in a safe place until it is certain that the patient's lungs were not adversly affected by the Colistimethate.  If it is discarded, valuable evidence may be lost.]
  • Healthcare professionals who use Colistimethate to treat patients with CF 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.  The side effects are as a result of local toxicity to the lung and airway.  More details of these effects are provided in the Information for Healthcare Professional.
  • Healthcare professionals who treat patients with CF should work out a treatment plan with their patients that best meets their needs.
  • Patients and/or their caregivers with questions or concerns about this advisory should contact their healthcare provider or their Cystic Fibrosis Care Center to determine how best to continue treating their infection.  [Patients who have been diagnosed with lung problems after inhaling Colistimethate should also contact the law firm of Pritzker | Ruonhonen for a free consultation regarding a possible Colistimethate lawsuit.  Families of patients who have died after inhaling Colistimethat should contact Pritzker | Ruohonen regarding a wrongful death lawsuit.]

You can find more details about Colistimethate in FDA’s Information for Healthcare Professionals and in the full prescribing information for Colistimethate.

The FDA urges both healthcare providers and patients to report side effects from medical products to MedWatch.  MedWatch reports may be made by phone:  1-800-FDA-1088; fax:  1-800-FDA-0178; or via the Internet at http://www.fda.gov/medwatch/index.htm. 
 
For liquid Colistimethate lawsuit information, including possible malpractice lawsuits against a pharmacy and prescribing doctor, please contact Pritzker | Ruohonen for a free consultation.  Call toll-free at 1-888-377-8900 or submit the Pritzker | Ruohonen online consultation form.


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