FDA issues safety alert on Intestinomicina marketed as treatment for infectious diarrhea

FDA is warning consumers not to use Intestinomicina (Laboratorios Lopez), a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a healthcare provider.

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 Oral forms of chloramphenicol were formally withdrawn from the United States market in July 2012 due to the risk of serious and life threatening injuries.

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. The product has been found in international grocery stores in the United States that feature South and Central American specialty foods and products.

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.

The product label 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.

Intestinomicina may also interact with other medications consumers may be taking.

Healthcare professionals and consumers are encouraged to report any adverse events related to Intestinomicina to 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 (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 (800) FDA-0178