FDA Warns of Dangers of El Salvadoran Intestinal Drug

The U.S. Food and Drug Administration (FDA) is warning consumers and health care professionals not to use Intestinomicina, a drug made in El Salvador to treat infectious diarrhea and acute gastrointestinal infections.

Why FDA Warns Consumers

The reason for the warning is that the medicine contains the prescription drug ingredient Chloramphenicol. The U.S. withdrew oral forms of chloramphenicol from the market in July 2012 because of the possibility of serious and life-threatening injuries.The label on the medicine is written primarily in Spanish, which calls the drug “chloramphenicol palmitato.” In English it is written as chloramphenicol.Oral chloramphenicol can cause bone marrow toxicity, which happens when not enough red blood cells, white blood cells, and/or platelets are made by the marrow, according to the FDA warning. The agent is sold primarily in international grocery stores in the U.S. that sell specialty foods and products from South and Central America.The label on the container of Intestinomicina also lists two antibacterial ingredients:

  • Neomycin, an antibiotic often contained in medications for people visiting the tropics
  • Sulfonamides or sulfa drugs

Both of these drugs can cause numerous types of adverse reactions including rashes, hives, and life-threatening effects.

FDA Advises

If you bought this product, the FDA advises you to stop taking it and talk to your health care provider. The product can be bought both as tablets or a liquid. It is made by Laboratorios Lopez.If you’ve experienced any adverse reactions, you and your doctor are encouraged by the FDA to file a report with the agency’s MedWatch Safety Information and Adverse Event Reporting Program. You can do so by:

  • Completing and submitting a report online
  • Downloading the form or requesting one by calling 1-800-332-1088, then completing it and returning it to the address on the form. You also can fax the form to 1-800-FDA-0178.

Source: FDAhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319850.htm

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