September 19, 2012
FDA has issued a warning to consumers about the use of Intestinomicina, a product used for the treatment of acute gastrointestinal infections and infectious diarrhea. Intestinomicina contains chloramphenicol, a prescription medication. Oral chloramphenicol was removed from the market in the US in July 2012 due to serious adverse reactions, such as bone marrow toxicity. Patients with anemia, decreases in platelets, or white or red blood cell deficiencies may be at an increased risk of death due to bone marrow toxicity when taking chloramphenicol.
Intestinomicina is manufactured in El Salvador by Laboratorios Lopez and is mostly labeled in Spanish. The product label lists “chloramfenicol palmitato” as a primary ingredient. In addition, the label lists other antibacterial agents, including neomycin and sulfonamides. Neomycin and sulfonamides, or sulfa drugs, may cause a range of adverse effects from rashes and hives to more severe and life-threatening reactions. Intestinomicina is produced in both tablet and liquid forms. This product can be found in the US at international grocery stores selling specialty foods and products from South and Central America. FDA is warning consumers who have Intestinomicina to immediately discontinue using it and to consult a healthcare professional.
Report any adverse events to FDA online at www.fda.gov/MedWatch/report.htm, or by phone at 1-800-332-1088.
Additional information on this alert is available from the following links:
- MedWatch Alert
- FDA Press Release
- Spanish FDA Press Release
September 19, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.