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FDA Recalls / Safety Alerts

FDA Warns Against Use Of Intestinomicina For Infectious Diarrhea

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

The U.S. Food and Drug Administration has warned consumers against using Intestinomicina, a drug product made in El Salvador and sold as a treatment for infectious diarrhea and acute gastrointestinal infections.

Intestinomicina contains the prescription drug ingredient, chloramphenicol, the oral use of which was formally withdrawn from the U.S. in July 2012 due to the risk of life threatening injuries.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 and is manufactured by Laboratorios Lopez. The product has been found in international grocery stores in the U.S. that feature South and Central American specialty foods and products.

Consumers who have purchased this product should immediately stop taking it and consult with a health care provider.

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.

The product label also lists antibacterial ingredients including neomycin, an antibiotic often found in topical medications, and sulfonamides, sometimes called sulfa drugs. These drugs have the potential to cause adverse reactions ranging from rashes and hives, to severe and life-threatening reactions.

Intestinomicina may also interact with other medications consumers may be taking, the FDA warned.

For comments and feedback contact: editorial@rttnews.com

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