FDA Warns Against Use of Diarrhea Drug From El Salvador
WEDNESDAY, Sept. 19 (HealthDay News) -- Consumers should not use a drug product called Intestinomicina -- marketed as a treatment for infectious diarrhea and acute gastrointestinal infections -- because it contains an ingredient that can cause serious and potentially deadly problems, the U.S. Food and Drug Administration warns.
People who bought Intestinomicina should immediately stop taking it and consult with a health care provider, the FDA said in a safety alert issued Tuesday.
Intestinomicina, which is made in El Salvador, contains a prescription drug ingredient called chloramphenicol. Earlier this year, in July, oral forms of chloramphenicol were taken off the U.S. market due to the risk of serious health problems.
The most dangerous threat associated with oral chloramphenicol is bone marrow toxicity, which occurs when the body does not produce enough red blood cells, white blood cells and/or platelets, the FDA noted in a news release.
While some types of bone marrow toxicity are reversible, in certain rare cases it can lead to death. Those at greatest risk for serious injury or death are patients with anemia, low white or red blood cell count, or decreased blood platelets.
Intestinomicina's label also lists antibacterial ingredients including neomycin, which is an antibiotic often found in topical medications, and sulfonamides (sulfa drugs). Neomycin and sulfa drugs can cause a variety of reactions, ranging from rashes and hives to severe and life-threatening reactions, the FDA said.
In addition, Intestinomicina may interact with other medications people may be taking, the FDA pointed out in the news release.
Intestinomicina -- made by Laboratorios Lopez -- is sold in tablet and liquid form by international grocery stores in the United States that feature South and Central American specialty foods and products.
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about diarrhea and its treatment.
SOURCE: U.S. Food and Drug Administration, news release, Sept. 18, 2012