FDA Warns Consumers Not to Buy Antimicrobial Dietary Supplements
The FDA has issued a warning regarding products marketed as antimicrobial dietary supplements which have been distributed in Colorado, Delaware, Texas, Florida, California, Georgia, and potentially other markets.
These antimicrobial dietary supplement products look like actual antimicrobial products available in Mexico. The products are marketed toward Hispanic consumers who may believe they will receive the beneficial health effects of an antimicrobial drug from these dietary supplements.
Consumers should not use dietary supplement products that also claim to be antimicrobial (antibiotic, antifungal or antiviral) drugs. These illegal products are falsely promoted with claims to treat illnesses such as upper respiratory infections, sinusitis, pneumonia, bronchitis and the common cold.
An antimicrobial is a substance that kills or inhibits the growth of pathogens such as bacteria, viruses and fungi. These products may or may not contain antimicrobials. Their use could delay treatment for serious illnesses (pneumonia, etc). These dietary supplement products are not FDA approved to treat, cure or prevent any medical conditions.
The FDA is aware of at least four cases in Texas in which children received emergency care due to worsening illnesses after being given products that the parents may have believed contained antimicrobials. It was determined the children had been given a product, Amoxilina, which the parents may have believed was the antimicrobial Amoxicillin. Giving the product to the children delayed legitimate medical treatment.
The products may be sold at various retailers, including small independent stores that cater to the Hispanic community. The package labels are printed in English and Spanish and mimics antimicrobials readily available in Mexico and possibly familiar to Hispanic consumers.
Consumers who have been using these types of products should consult their health care providers immediately. Consumers should be skeptical of any product that claims to be a dietary supplement and claims to treat, prevent or cure disease or contain an antimicrobial.
Various companies market these products. The FDA is aware of several products listed below, but note the list may not be complete. Products include Amoxilina Capsules 500 mg (30 caps, Amoxilina Suspension (3.4 Oz), Pentreximil Plus 500 Mg (30 Caps), and Pentreximil Plus Syrup 3.4 Oz distributed by Multi-Mex and Pentrexyl Forte Natural, 30-capsule box containing capsules in blister packs distributed by Phoenix Import & Distribution.
The information is available in Spanish at the FDA’s website here.
The FDA will update their information as it becomes available. For updates, check here.