In a May 2011 press release, the Food and Drug Administration (FDA) warned consumers about the potential dangers of using products advertised as dietary supplements that are also marketed as antimicrobial (antibiotic, antifungal or antiviral) drugs. According to the FDA, these antimicrobial dietary supplements are illegal and falsely marketed to treat illnesses like upper respiratory infections, sinusitis, pneumonia, bronchitis and the common cold.
The FDA is advising consumers to stop using these products and contact their healthcare providers. It has been determined that the labeling on several of these products is designed to mimic that used on legitimate medications available in Mexico. These dangerous products seem to be marketed toward the Latino community.
The FDA is warning consumers that using these products could delay treatment for severe illnesses. Moreover, these products are not approved by the FDA to treat, cure or prevent any specific medical conditions. The FDA has received reports of at least four cases in Texas in which children had to receive emergency care because of worsening illnesses after taking products that their parents may have thought contained antimicrobials.
Consumers and health care professionals are being asked to report severe side effects, product quality problems and other adverse events associated with the use of products marketed as antimicrobial dietary supplements to the FDA’s MedWatch Adverse Event Reporting program: https://www.accessdata.fda.gov/scripts/medwatch2 or 800-FDA-1088.
The referenced dietary products include:
- Amoxilina Capsules 500 Mg (30 Caps)
- Amoxilina Suspension (3.4 Oz)
- Pentreximil Plus 500 Mg (30 Caps)
- Pentreximil Plus Syrup 3.4 Oz
- Pentrexyl Forte Natural, 30-capsule box containing capsules in blister packs
Marketing misrepresentation and labeling errors for over-the-counter medications and other products, as well as errors in the labeling of prescription drugs, may present potential risks for consumers. The New Jersey product liability attorneys at Blume Forte have the experience and resources that are needed to provide individuals with a comprehensive review of their potential dangerous drug claim. For a no-cost consultation, call 973-635-5400.