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FDA: Serious risks associated with Intestinomicina
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The FDA issued a warning Sept. 18 on a risk for life-threatening injury associated with Intestinomicina, a drug used to treat acute gastrointestinal infections and infectious diarrhea.
According to a press release, Intestinomicina (Laboratorios Lopez) contains chloramphenicol, which was removed from the US market in oral form in July after being associated with conditions including bone marrow toxicity. Risk for injury or death is elevated among patients with anemia, low white or red blood cell count or decreased blood platelets.
Other Intestinomicina ingredients, including neomycin and sulfonamides, also may cause potentially life-threatening reactions and adverse events including hives and rashes.
The drug is manufactured in El Salvador and distributed in liquid and tablet forms in grocery stores featuring products and foods from South and Central America, according to the release.
The FDA recommended that health care professionals submit any adverse events reported by patients that could be associated with the product to the MedWatch Safety Information and Adverse Event Reporting Program.