FDA Alert: Intestinomicina (contains chloramphenicol) by Laboratorios Lopez: Safety Alert – Contains Drug Ingredient Withdrawn from US

FDA is warning consumers not to purchase or use Intestinomicina, a drug marketed for infectious diarrhea, due to its containing unnaproved and dangerous ingredients.  A quick Google search by PSM turned up several Spanish-language websites offering the drug for sale.

This is a reprint of an FDA Alert.

AUDIENCE: Consumer, Health Professional

ISSUE: FDA is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Intestinominica contains the prescription drug ingredient, chloramphenicol. Oral forms of chloramphenicol were formally withdrawn from the United States market in July 2012 due to the risk of serious and life threatening injuries. The most serious and life-threatening injury associated with oral chloramphenicol treatment is bone marrow toxicity, which occurs when the body does not produce enough red blood cells, white blood cells, and/or platelets. Certain types of bone marrow toxicity are reversible; however, in rare circumstances it can lead to death. Patients with anemia, low white or red blood cell count, or decreased blood platelets may be at a greater risk of death or serious injury.

BACKGROUND: Intestinomicina is marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Intestinomicina is labeled primarily in Spanish and lists the ingredient as “chloramfenicol palmitato,” or chloramphenicol in English, on the label. It can be found in tablet and liquid forms and is manufactured by Laboratorios Lopez. The product has been found in international grocery stores in the United States that feature South and Central American specialty foods and products.

The product label for Intestinomicina also lists antibacterial ingredients including Neomycin, an antibiotic often found in topical medications, and Sulfonamides, sometimes called sulfa drugs. Neomycin and sulfa drugs have the potential to cause a variety of adverse reactions, ranging from rashes and hives, to severe and life-threatening reactions.

RECOMMENDATION: Consumers who have purchased this product should immediately stop taking it and consult with a health care provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 [09/18/2012 – Press Release – FDA]

[09/18/2012 – (Spanish) Press Release – FDA]