Coly-Mycin M use via nebulizer associated with a death
Yesterday the FDA issued a public health advisory regarding a risk of death associated with the use of Coly-Mycin M and generic forms of colistimethate when used in a premixed form for inhalation with a nebulizer. Although colistimethate is only approved by the FDA for intravenous or intramuscular injection, it is often prescribed to treat cystic fibrosis patients with Pseudomonas infections by mixing it with sterile water to form a solution for inhalation via a nebulizer. Use of premixed, ready-to-use solutions could lead to lung injury or death.
>>INFORMATION: FDA Coly-Mycin M Side Effect Alert
The FDA is investigating a report that one cystic fibrosis patient died after using a liquid solution of Coly-Mycin M which was premixed by a pharmacy and dispensed as prescribed in a ready-to-use dose. In April 2007, the individual with CF developed respiratory distress within hours of inhaling the solution via a nebulizer. Over several days, the condition progressed to acute respiratory failure which required intensive care treatment and eventually caused death due to multi-organ system failure 19 days later.
The Coly-Mycin M problems appear to be connected with the premixing and storing of the solution for future use. When mixed with water and a buffer, colistimethate undergoes a spontaneous hydrolysis to a bioactive form of colistin. Storing the solution for longer than 24 hours increases the concentrations of colistin in the solution, which can be toxic to the lungs.
The FDA has recommended that if a healthcare provider chooses to prescribe Coly-Mycin M or a generic colistimethate for inhalation, it should be administered promptly after it is mixed to avoid this toxicity. Patients should not use any pre-mixed, ready-to-use, liquid forms of Coly-Mycin M or colstimethate via a nebulizer, which turns the liquid into a mist and delivers it directly to the lungs.
If you, a friend or family member suffered a lung injury or death after using Coly-Mycin M or colstimethate in a liquid form, request a free consultation to review the legal options which may be available.
