FDA Warns Intestinomicina Can Lead to Life-Threatening Injuries

The U.S. Food & Drug Administration (FDA) is warning consumers that the drug Intestinomicina can lead to life-threatening injuries. The drug is made in El Salvador and advertised as a treatment for infectious diarrhea and acute gastrointestinal infections.

Intestinomicina, which is an over-the-counter (OTC) medication, said The Associated Press (AP), contains the prescription drug ingredient, chloramphenicol. Oral forms of this drug ingredient were previously withdrawn from the United States market this July over risks of serious and life threatening injuries.

The Intestinomicina label is mostly written in Spanish, but does list the ingredient as “chloramfenicol palmitato,” or “chloramphenicol” in English. The product, which is made in both tablet and liquid forms and is manufactured by Laboratorios Lopez, can be found in international grocery stores in the U.S. that feature South American and Central American specialty foods and products.

The most serious and life-threatening injury associated with oral chloramphenicol treatment is bone marrow toxicity. This occurs when the body does not produce sufficient red blood cells, white blood cells, and/or platelets. Certain types of bone marrow toxicity are reversible; however, in rare circumstances bone marrow toxicity is fatal. Patients with anemia, low white or red blood cell count, or decreased blood platelets may be at increased risk for death or serious injury.

The Intestinomicina label also lists antibacterial ingredients that include 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, from rashes and hives, to severe and life-threatening reactions. Intestinomicina may also interact with other medications.

The agency is advising consumers in possession of Intestinomicina to stop taking the medication and consult a health care professional, said the AP.

The FDA notes that health care professionals and consumers are encouraged to report any adverse events related to Intestinomicina to the agency’s MedWatch Safety Information and Adverse Event Reporting Program: Online at www.fda.gov/Medwatch/report.htm; by telephone at 1.800.FDA.1088 (1.800.332.1088), or by mail or fax by returning FDA form 3500, available on the MedWatch “Download Forms” page. Mail to the address on the pre-addressed form or fax to 1.800.FDA.0178 (1.800.332.0178).

This entry was posted in Pharmaceuticals and tagged . Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.