Safety Warning Concerning the Use of Blue Food Dye in Enteral Feedings - Notice to Hospitals

Date: 2003-12-19

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The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

from the Marketed Health Products Directorate,
Food Directorate and Therapeutic Products Directorate

December 16, 2003

To: Hospital Chief of Medical Staff

Please forward to all health professionals who prescribe and/or prepare enteral feedings, especially in ICU settings and post this NOTICE in your institution.

Safety Warning Concerning the Use of Blue Food Dye in Enteral Feedings

This is to inform you about a recent warning announcement made by the United States Food and Drug Administration (US FDA) on September 29, 2003 regarding reports of blue discolouration and death in patients receiving enteral feedings tinted with FD & C Blue No. 1 (Blue 1) dye (  http://www.cfsan.fda.gov/%7Edms/col-ltr2.html).

There were several reports of toxicity, including death, temporally associated with the use of FD & C Blue No. 1 (Blue 1) in enteral feeding solutions. The dye was used to help detection and/or monitoring of pulmonary aspiration in patients being fed by an enteral feeding tube. Reported episodes were manifested by blue discolouration of the skin, urine, faeces or serum and were associated with serious complications such as refractory hypotension, metabolic acidosis and death. Seriously ill patients, particularly those with a likely increase in gut permeability, may be at greater risk.

FD & C Blue No. 1 is known in Canada as Brilliant Blue FCF (CAS No. 3844-45-9). Health Canada has never specifically acceded to the use of Brilliant Blue in enteral feeding solutions. Brilliant Blue is added to enteral feeding solutions at the discretion of the physician. Health Canada is not aware of any reported cases of toxicity in Canada. Brilliant Blue FCF dye is used in a number of food products.

Health care professionals should be aware of the following points:

• use of Brilliant Blue FCF (FD & C Blue No. 1) tinted enteral feedings for detecting aspiration has been associated with serious adverse events, including death, although a direct causal relationship has not been established.
• the safety of Brilliant Blue FCF (FD & C Blue No. 1)-tinted enteral feedings has not been documented.
• based on available reports, patients at risk for increased intestinal permeability (including sepsis, burns, trauma, shock, surgical interventions, renal failure, celiac sprue, inflammatory bowel disease) appear to be at increased risk of absorbing the dye.
• Brilliant Blue FCF (FD & C Blue No. 1) tinted enteral feedings may also interfere with diagnostic stool examinations, such as tests for detection of occult blood.
• other blue dyes, such as methylene blue, may have similar if not greater toxicity potential and would not be appropriate replacements.

Health Canada asks that you share this information with your staff or membership and encourage their implementation in the interest of patient safety.

The identification, characterization, and management of drug-related adverse events is dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Health care professionals are asked to report any suspected adverse reactions in patients receiving Brilliant Blue FCF (FD & C Blue No. 1) tinted enteral feedings , to the appropriate manufacturer or to the Marketed Health Products Directorate at the following address:

Any suspected adverse incident can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.